127

CHAPTER 4. DISSERTATIONS ON MACULAR

DEGENERATION

Overview

In this chapter, we will give you a bibliography on recent dissertations relating to macular degeneration. We will also provide you with information on how to use the Internet to stay current on dissertations. IMPORTANT NOTE: When following the search strategy described below, you may discover non-medical dissertations that use the generic term “macular degeneration” (or a synonym) in their titles. To accurately reflect the results that you might find while conducting research on macular degeneration, we have not necessarily excluded non-medical dissertations in this bibliography.

Dissertations on Macular Degeneration

ProQuest Digital Dissertations, the largest archive of academic dissertations available, is located at the following Web address: http://wwwlib.umi.com/dissertations. From this archive, we have compiled the following list covering dissertations devoted to macular degeneration. You will see that the information provided includes the dissertation’s title, its author, and the institution with which the author is associated. The following covers recent dissertations found when using this search procedure:

•Age-related Macular Degeneration: Neuropsychological Differences in Scores between Successful and Unsuccessful CCTV Users on Selected Tests by Kruger, Daniel E.; PhD from The University of Arizona, 2002, 101 pages http://wwwlib.umi.com/dissertations/fullcit/3060984

•Analysis of the Gene and Protein Causing Best Macular Dystrophy by Bakall, Benjamin; PhD from Uppsala Universitet (Sweden), 2003, 42 pages http://wwwlib.umi.com/dissertations/fullcit/f30577

•Associations among Comorbidities, Visual Acuity, and Quality of Life in Patients with Age-related Macular Degeneration and Central Vision Loss by Miskala, Paivi Helena; PhD from The Johns Hopkins University, 2002, 143 pages http://wwwlib.umi.com/dissertations/fullcit/3046519

128 Macular Degeneration

Keeping Current

Ask the medical librarian at your library if it has full and unlimited access to the ProQuest Digital Dissertations database. From the library, you should be able to do more complete searches via http://wwwlib.umi.com/dissertations.

130Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): Alcon Research

Purpose - Excerpt: To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12and 24-month visits.

Phase(s): Phase III

Study Type: Interventional

Contact(s): Alcon Clinical 817-568-6747 IntlDev@alconlabs.com Web Site: http://clinicaltrials.gov/ct/show/NCT00051129

•Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will determine whether the drug celecoxib (Celebrex(r) (Registered Trademark)) can help stabilize or improve vision in patients with agerelated macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina-that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss. However, the treatment usually does not cause vision to improve, and it has only a temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work in all patients and may actually cause some swelling and re-growth of blood vessels. Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of PDT. Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be eligible for this study. Participants will be randomly assigned to take either celecoxib or a placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and procedures detailed below. Not every examination will be done at every visit, but all may be required at one visit. -Medical history and physical examination -Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney function -Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined -Photography: Photographs of the eye are taken using a special camera with a bright flash -Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. The retina is photographed using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. -Indocyanine green angiography: This procedure, similar to fluorescein angiography, uses a green dye to photograph the retina and identify portions of abnormal vessels in the deepest part of the retina. -Optical coherence tomography: This new technique uses light to produce a 2-dimensional cross-sectional picture of the retina. The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights, first with one eye

Clinical Trials 131

and then the other. One week after starting the study medications, laser treatment will begin. For this procedure, a needle is placed in an arm vein and a chemical called verteporfin (Visudyne(r) (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds. Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations and possible re-treatment, if needed. Some patients will be asked to return 1 to 2 weeks after the first PDT for an eye examination and fluorescein angiography.

Phase(s): Phase II

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00043680

•Effect of DHA Supplements on Macular Function in Patients with Stargardt Macular Dystrophy and Stargardt-like Macular Dystrophy

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will evaluate whether docosahexaenoic acid (DHA) dietary supplementation can improve macular function in patients with Stargardt macular dystrophy and Stargardt-like macular dystrophy. Stargardt macular dystrophy is a recessive inherited trait that causes a severe form of macular degeneration. (The macula is the center part of the retina in the back of the eye that is responsible for fine vision.) The disorder begins in late childhood and progresses to a significant decrease in central vision. One of the earliest signs of the disorder is accumulation in and under the macula of a fatty pigment called lipofuscin. Stargardt-like macular dystrophy is a dominant inherited trait involving loss of central vision, but it begins later than Stargardt macular dystrophy, and the accumulation of lipofuscin extends beyond the central region of the macula. DHA is a fatty acid that is essential for normal brain and eye development. It is normally found in the diet, but not in large amounts. Supplements may help prevent or slow the progression of some eye diseases. Patients with autosomal dominant Stargardt-like macular dystrophy or autosomal recessive Stargardt macular dystrophy are eligible for this study. Candidates will be screened with the following tests and procedures: - Medical history and physical examination. - Blood test to measure levels of DHA and vitamins. - Eye examination: The patient's vision and eye pressure are tested, then the pupils are dilated to examine structures inside the eye. Photographs are also taken. - Visual field test: The patient looks at a tiny spot of light projected onto a white screen and is asked to note when other lights appear at other places on the screen. - Electroretinogram (ERG): An electrode (small silver disk) is taped to the patient's forehead. Drops are given to numb the eyes and special contact lenses are inserted in the eyes. For the first part of the test, the patient looks at the center of a black and white checkerboard screen that flickers for 30 seconds at a time. This is repeated 16 or more times. For the second part of the test, the patient looks inside a sphere, in which flashes of light flicker for 20 seconds at a time. This is repeated four or more times. The contact lenses sense small electrical signals generated by the retina during the tests. Participants will begin taking DHA capsules or a placebo (look-alike capsules with no active ingredient) from 1 week to 3 months after enrolling in the study and will repeat several of the screening tests at follow-up visits scheduled 3, 6, 9, 12, and

132Macular Degeneration

15 months after they start taking the capsules. They will also be interviewed about any treatment side effects.

Phase(s): Phase I

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00060749

•Efficacy and Safety Study of rhuFab V2 (Ranibizumab) to Treat Age-Related Macular Degeneration

Condition(s): Age-Related Maculopathy

Study Status: This study is currently recruiting patients. Sponsor(s): Genentech

Purpose - Excerpt: The purpose of this study is to determine whether injections of rhuFab into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00056836

•Genetic Factors in Age-Related Macular Degeneration

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will examine whether certain polymorphisms (small gene variances) predispose people to develop age-related macular degeneration (AMD). This eye condition affects people over 50 years of age and can cause permanent loss of central vision. The study will examine and compare the frequency of polymorphisms in patients with AMD to that of individuals without AMD. This information will help identify genetic risk factors for the AMD and may lead to the development of more effective treatments. Patients 50 years of age and older with advanced AMD and healthy normal volunteers may be eligible for this study. All participants will provide an eye health history and will have 10 milliliters (2 teaspoons) of blood drawn from an arm vein. The DNA in the blood will be isolated and tested for certain genes that other research indicates are important in aging and age-related diseases. The normal and polymorphic gene sequences will be identified and compared in patients with AMD and control subjects to determine if any of the polymorphisms are related to development of AMD. In addition, control subjects will have a routine eye examination, including dilation of the pupils for examination of the back of the eye.

Study Type: Observational Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00058695

Clinical Trials 133

•Identification and Treatment of Feeder Vessels in Macular Degeneration

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will try to identify and treat feeder vessels in age-related macular degeneration. The macula is the part of the retina in the back of the eye that determines central or best vision. In macular degeneration, leaking blood vessels under the macula lead to loss of central vision. These vessels branch out tree-like from one or more feeder vessels. Instead of treating all the abnormal branching vessels, this study will try to find and close only the feeder vessels, thereby depriving the abnormal vessels of nutrition. The vessels will be closed with laser beam treatment. People 50 years of age and older with macular degeneration and visual acuity worse than 20/50 in the study eye and the same or better vision in the other eye may be eligible for this study. Candidates will undergo fluorescein angiography to try to locate feeder vessels. For this procedure, a yellow dye is injected into an arm vein. The dye travels to the blood vessels in the eyes, and pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Before laser treatment, participants will have a complete eye examination, including measurement of visual acuity, evaluation of the front part of the eye with a slit lamp microscope, examination of the retina with an ophthalmoscope, and measurement of eye pressure using a tonometer. During the laser treatment phase of the study, participants will have indocyanine green angiography-a procedure similar to fluorescein angiography, but using a green dye-to photograph the retina and identify feeder vessels. If feeder vessels are located, laser beam treatment will begin. For this procedure, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye for the laser treatment. The number of treatments depends on how well the individual patient responds, but usually between two and eight treatments are required. The indocyanine green angiogram will be repeated after the laser beam treatment to determine if the feeder vessels have been successfully closed. If the vessels remain partially open, a repeat application will be done, followed by another indocyanine green angiogram to check the results. Patients will be checked in the clinic after 1 week to see if additional treatment is needed. If so, re-treatment will be done in a week. If no re-treatment is required, follow-up visits will be scheduled 2, 3, and 6 weeks after treatment, 3 and 6 months after treatment, and every 6 months after that for 2 years to evaluate treatment results. The evaluations will include fluorescein angiograms and other examinations that were done before starting treatment. If abnormal vessels are still present or growing, repeat treatments will be applied following the same procedure.

Phase(s): Phase I

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00018070

•Laser and Medical Treatment of Diabetic Macular Edema

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

134Macular Degeneration

Purpose - Excerpt: This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina, a thin layer of tissue that lines the back of the eye become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision may also swell, causing vision loss. Traditional laser treatment (argon blue or green or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. Studies with a different type of laser (diode) may be less damaging. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. This study will also examine whether celecoxib (Celebrex(r) (Registered Trademark)), an antiarthritis drug that reduces inflammation and swelling, can reduce inflammation and swelling of the retina. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction. Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema that requires laser treatment may be eligible for this study. Candidates will be screened with the following tests and procedures: - Medical history: to review past medical conditions and treatments. - Physical examination: to measure vital signs (pulse, blood pressure, temperature, breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs. - Eye examination: to assess visual acuity (eye chart test) and examine pupils, lens, retina, and eye movements. The pupils will be dilated with drops for this examination. - Blood tests: to measure cholesterol, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function. - Eye photography: to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on the eye condition. - Fluorescein angiography: to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be randomly assigned to take celecoxib or placebo (an inactive, lookalike pill). Participants who have elevated cholesterol levels may return for a brief visit after 1 month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who require laser treatment will be randomly assigned to one of the two laser treatments. For these procedures, eye drops are put in the eye to numb the surface and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The maximum number of treatments depends on how well the treatment is working. Patients who respond well to the study medication may receive no laser treatments. After the first year, patients will be followed every 6 months until either the patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During the follow-up visits, patients' response to treatment will be evaluated with repeat tests of several of the screening exams.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00050479

Clinical Trials 135

•Open-Label Posterior Juxtacleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients with AMD

Condition(s): Macular Degeneration

Study Status: This study is currently recruiting patients. Sponsor(s): Alcon Research

Purpose - Excerpt: A 24 month study of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Phase(s): Phase III

Study Type: Interventional

Contact(s): Alcon Call Center 866-692-5959 wetamd@inveresk.com; Alcon Clinical (817)568-6747 intldev@alconlabs.com

Web Site: http://clinicaltrials.gov/ct/show/NCT00065728

•Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders

Condition(s): Macular Degeneration; Retinal Vein Occlusion Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, 'Kenalog-40 Injection' produced by Bristol Myers Squibb, has not been formulated for intraocular use. This formulation when used intraocularly has been associated with cases of non-bacterial endophthalmitis, which is thought to be due to the presence of benzyl alcohol and/or polysorbate 80. Both are suspected irritants. The purpose of this study is to evaluate the safety of a novel preservative-free formulation of triamcinolone acetonide (TAC-PF) at four dosage levels. The study will be an open-label, single-masked, randomized Phase I study that will investigate the safety and potential efficacy of the new formulation of TAC-PF. Sixteen participants with retinal vascular disease will be randomly assigned to receive via intravitreal injection at one of 4 dose levels (1 mg, 4 mg, 8 mg, or 16 mg) of TAC-PF. Depending on a participant's response, injections may be repeated at up to 3 month intervals. Participants will be followed for 3 years. The primary outcome will be an assessment of post-injection intraocular toxicity related events including increased inflammation, increased intraocular pressure, significant decreases in BCVA, cataract formation, retinal detachment, and intraocular hemorrhage. The secondary outcomes will be an improvement of 15 letters in best-corrected visual acuity (BCVA, ETDRS) from baseline to year 3, and decreases in retinal thickening and area of leakage.

Phase(s): Phase I

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00071227

•Preventing Depression in Patients with Macular Degeneration

Condition(s): Depression; Macular Degeneration Study Status: This study is currently recruiting patients.

136Macular Degeneration

Sponsor(s): National Institute of Mental Health (NIMH)

Purpose - Excerpt: The purpose of this study is to evaluate the efficacy of a brief, standardized cognitive psychotherapy called Problem Solving Treatment (PST) to prevent depression in elderly patients with age-related macular degeneration (AMD).

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00042211

•Safety & Efficacy Study of rhuFab V2 in Combination with Verteporfin for treatment of Age-related Macular Degeneration

Condition(s): Age-Related Maculopathy

Study Status: This study is currently recruiting patients. Sponsor(s): Genentech

Purpose - Excerpt: The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy is a safe and efficacious treatment for patients with age-related macular degeneration.

Phase(s): Phase I; Phase II Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00056823

•Safety and Efficacy Study of rhuFAb V2 (Ranibizumab) to Treat Age-Related Macular Degeneration

Condition(s): Age-Related Maculopathy

Study Status: This study is currently recruiting patients. Sponsor(s): Genentech

Purpose - Excerpt: The purpose of this study is to evaluate the safety and efficacy of Lucentis (ranibizumab) compared with verteporfin photodynamic therapy in preventing vision loss associated with age-related macular degeneration.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00061594

•Screening for Studies on Retinovascular Diseases

Condition(s): Diabetic Retinopathy; Macular Degeneration; Pathologic Neovascularization; Retinal Disease

Study Status: This study is currently recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies of the retina, such as diabetic retinopathy and macular degeneration. Patients must meet the specific criteria of a research study, and

Clinical Trials 137

this protocol serves as a first step for admitting patients to a retinal disease study. Candidates will undergo a medical history and comprehensive eye examination. The eye examination includes dilation of the pupils to fully examine the retina. In some studies, photographs of the eye are required. This is done using fluorescein angiography. In this procedure, a dye called sodium fluorescein is injected into the blood stream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Other diagnostic procedures may include physical examination, questionnaires, routine laboratory tests and other standard or specialized tests, as needed. When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

Study Type: Observational Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00001733

•A Study to Evaluate Retisert in the Treatment of Patients with the "wet" form of AgeRelated Macular Degeneration

Condition(s): Macular Degeneration

Study Status: This study is no longer recruiting patients.

Sponsor(s): Control Delivery Systems; Bausch & Lomb Pharmaceuticals

Purpose - Excerpt: A study evaluating Retisert in patients with age-related macular degeneration

Phase(s): Phase II

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00032396

•Age-Related Eye Disease Study (AREDS)

Condition(s): Macular Degeneration; Cataract; Lens Opacities Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To assess the clinical course, prognosis, and risk factors of age-related macular degeneration (AMD) and cataract. To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1) antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and progression of lens opacities.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000145

•Age-Related Macular Degeneration and Cataract

Condition(s): Cataract; Macular Degeneration

138Macular Degeneration

Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: Clouding of the lens, or cataract formation, accounts for vision loss in about 45 percent of the U.S. population aged 75 to 85 years. Macular degenerationdestruction of the part of the retina responsible for central vision used in reading-is the leading cause of legal blindness in people over 60 years of age. This 10-year study on age-related macular degeneration and cataract will investigate: 1. The natural course and prognosis of these diseases; 2. The effects of vitamin and mineral supplements on their development and progression; and 3. Risk factors associated with their development. Patients with age-related macular degeneration or cataract will be evaluated for their eligibility in this study with a medical history, vision test and thorough eye examination, including photographs of the lens and back of the eye. Those accepted to the study will be randomly assigned to take one of the following 4 times a day: 1) a vitamin only; 2) a mineral only; 3) both a vitamin and a mineral; or 4) a placebo (a tablet with no active ingredient). A blood sample will be drawn at the beginning of the study and once a year until its end to measure vitamin and mineral blood levels and to study their effects on cholesterol. Participants will be asked to complete a voluntary questionnaire about their visual function and how it affects their daily lives. Some patients may be asked to participate in two interviews about 6 months apart, in which they will provide information on their food intake over a 24-hour period. This information will be used to explore possible dietary risk factors for macular degeneration and cataract. Participants may also be asked to provide a small blood sample for use in studying possible hereditary factors associated with age-related macular degeneration. This research may lead to a better understanding of why the condition develops, who is likely to be affected and to what degree, and how to improve treatment.

Phase(s): Phase II

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00001312

•Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)

Condition(s): Macular Degeneration

Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To determine whether application of low-intensity laser treatment of eyes with drusen in the macula can prevent later complications of age-related macular degeneration and thereby preserve visual function.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000167

•Macular Photocoagulation Study (MPS)

Condition(s): Choroidal Neovascularization; Macular Degeneration; Histoplasmosis

Clinical Trials 139

Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To evaluate laser treatment of choroidal neovascularization (CNV) through randomized, controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets of randomized, controlled clinical trials. Change in bestcorrected visual acuity from baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated in each set of trials. The purpose of each is described below. Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss of central vision in patients with age-related (senile) macular degeneration (AMD), presumed ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial was conducted for each of the three underlying conditions. Krypton Study: To determine whether krypton red laser photocoagulation of choroidal neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH, and INVM. A separate trial was conducted for each of the three underlying conditions. Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or delaying further visual acuity loss in patients with new (never treated) or recurrent (previously treated with laser photocoagulation) choroidal neovascularization under the center of the FAZ. Two separate trials, one for each type of lesion, were carried out.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000158

•Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study

Condition(s): Atherosclerosis; Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Cerebrovascular Disorders; Heart Failure, Congestive; Myocardial Infarction; Heart Diseases; Diabetes Mellitus, non-insulin dependent; Hypertension; Diabetic Retinopathy; Macular Degeneration; Diabetes Mellitus

Study Status: This study is no longer recruiting patients. Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI)

Purpose - Excerpt: To evaluate the relation of retinal microvascular characteristics to subclinical cardiovascular disease, clinical disease, and their risk factors in the MultiEthnic Study of Atherosclerosis (MESA) cohort.

Study Type: Observational Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00041444

•Phase 3 Study to evaluate Anecortave Acetate vs. Visudyne for the treatment of the wet form of AMD.

Condition(s): Macular Degeneration

Study Status: This study is no longer recruiting patients.

140Macular Degeneration

Sponsor(s): Alcon Research

Purpose - Excerpt: The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00041483

•Randomized Trial of Beta-Carotene and Macular Degeneration

Condition(s): Macular Degeneration

Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000152

•Randomized Trials of Vitamin Supplements and Eye Disease

Condition(s): Macular Degeneration; Cataract

Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000161

Clinical Trials 141

•Submacular Surgery Trials (SST)

Condition(s): Macular Degeneration; Histoplasmosis Study Status: This study is no longer recruiting patients. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often than observation. To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS, or idiopathic causes changes the patient's perception of healthand vision-related "quality of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36 (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). To determine whether randomized trials of surgery are warranted for patients with subfoveal CNV associated with age-related macular degeneration not suitable for laser treatment.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000150

•Branch Vein Occlusion Study

Condition(s): Macular Degeneration; Neovascularization, Pathologic; Vitreous Hemorrhage

Study Status: This study is completed. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: To determine whether scatter argon laser photocoagulation can prevent the development of neovascularization. To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous hemorrhage. To determine whether macular argon laser photocoagulation can improve visual acuity in eyes with macular edema reducing vision to 20/40 or worse.

Phase(s): Phase III

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00000162

•Diabetic Retinopathy and Visual Function Study

Condition(s): Diabetic Retinopathy; Macular Degeneration; Vision, Subnormal Study Status: This study is completed.

Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and

142Macular Degeneration

contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

Study Type: Observational Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00001346

•Fluocinolone Implant to Treat Macular Degeneration

Condition(s): Choroidal Neovascularization; Macular Degeneration Study Status: This study is completed.

Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration. This eye disease can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. It is the leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves and releases the medication into the fluid in the eye. Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels leak blood under the macula, the part of the retina that determines central vision. Tissue studies show evidence of inflammation in the retinas of patients. This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss. Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision. Patients 50 years of age and older with age-related macular degeneration may be eligible for this study. Study patients will be randomly assigned to one of two treatment groups. One will receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the implants can release the medicine for 2 to 3 years. Participants will have a medical history, physical examination and complete eye examination. The latter will include a vision test, eye pressure measurement, examination of the pupils, lens, retina, and eye movements. Photographs of the eye will be taken with a special camera. Patients will also undergo fluorescein angiography, a test that takes pictures of the retina using a yellow dye called sodium fluorescein. The dye is injected into the blood stream through a vein. After it reaches the blood vessels of the eye, photographs are taken of the retina. When the above tests are completed, patients will be scheduled for surgery to place the implant. The procedure will be done under either local or general anesthesia. Follow-up visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after surgery, and then every 6 months until the implant is depleted of medicine or is removed. Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects, if any.

Phase(s): Phase I

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00008515

Clinical Trials 143

•Long Term Follow-Up of Diabetic Retinopathy

Condition(s): Blindness; Cataract; Diabetes Mellitus; Diabetic Retinopathy; Macular Degeneration

Study Status: This study is completed. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: The efficacy of laser photocoagulation treatment for diabetic retinopathy has been demonstrated by several National Eye Institute (NEI) sponsored clinical trials. The Diabetic Retinopathy Study (DRS) demonstrated that scatter photocoagulation reduces the risk of blindness from diabetic retinopathy. The Early Treatment Diabetic Retinopathy Study (ETDRS) extended these findings by providing information on when to initiate scatter photocoagulation and by demonstrating that focal treatment was effective in treating macula edema. The Krypton Argon Regression Neovascularization Study (KARNS) showed that scatter photocoagulation with krypton red laser was just as safe and effective as the argon blue-green laser in the treatment of proliferative diabetic retinopathy. Unfortunately, there is little data on the long term effects of photocoagulation on visual function. The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy. A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes. All patients previously treated with laser photocoagulation (focal and/or scatter) are eligible to participate in this long term study. The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment. Study evaluations will include a standard ophthalmic examination, fluorescein angiography, lens and fundus photography.

Study Type: Observational Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00001395

•Lutein for Age-Related Macular Degeneration

Condition(s): Macular Degeneration Study Status: This study is completed. Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: This study will examine whether taking the vitamin lutein changes lutein blood levels. Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease age-related macular degeneration, but more information is needed to support this. Age-related macular degeneration can significantly impair the ability to read, drive, and carry out daily activities. It is the most common cause of vision loss in people over age 60. Lutein a carotenoid that occurs naturally in the retina (the back part of the eye), especially the macula-the part of the retina that is important for fine, detailed vision. Men and women 60 years of age and older, with or without agerelated macular degeneration, may be eligible for this study. Candidates will undergo the following tests: 1. Medical history and physical examination. 2. Eye examinationIncludes evaluation of visual acuity, measurement of eye pressure, examination of the lens, retina, pupils and eye movements, and photographs of the eye. 3. Visual field study-Examines the ability to see objects in the periphery. The subject looks at a target on a screen and indicates when lights that appear in other places on the screen are visible. 4. Flicker photometry-The subject looks at a flashing light and turns a knob until

144Macular Degeneration

the light stops flashing. 5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function, cholesterol and triglycerides. Participants will be randomly assigned to take one of three dosages of lutein (2.5 milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many of the exams described above will be repeated to evaluate the effects of lutein treatment on the eye.

Phase(s): Phase II

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00006202

•Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration

Condition(s): Choroidal Neovascularization; Macular Degeneration Study Status: This study is completed.

Sponsor(s): National Eye Institute (NEI)

Purpose - Excerpt: Age-related macular degeneration (AMD) represents the most common cause of blindness in patients over the age of 60. The major cause of vision loss in this disease is due to the development of choroidal neovascular membrane formation (CNVM). Several clinical trials have proven that eyes with "well-defined" CNVM or lesions that can be readily demarcated with fluorescein angiography can be successfully treated with laser photocoagulation. However, up to 87% of eyes present with "illdefined" CNVM or lesions that cannot be well demarcated on fluorescein angiography and are not amenable to laser photocoagulation. No beneficial treatment for this form of choroidal neovascularization has been established. Histopathologic study has demonstrated the presence of inflammatory and reparative responses in the retina of patients with ill-defined choroidal neovascularization. Since corticosteroids have been shown to downregulate many of the cellular factors involved in both inflammation and repair, the present study is designed to assess the ability of corticosteroid injection around the eye to prevent severe vision loss associated with "ill-defined" choroidal neovascularization in the setting of age-related macular degeneration. The study will be organized as a randomized open label control clinical trial involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety of this treatment modality. Phase 2 will place emphasis on efficacy of the study.

Phase(s): Phase I

Study Type: Interventional Contact(s): see Web site below

Web Site: http://clinicaltrials.gov/ct/show/NCT00001615

•Phase II/III study of anti-VEGF in neovascular AMD

Condition(s): Macular Degeneration; Choroidal Neovascularization Study Status: This study is completed.

Sponsor(s): Eyetech Pharmaceuticals