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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00766649 |
This study will examine the safety and effectiveness of sirolimus in preserving vision in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD). The macula is the central part of the retina responsible for sharp vision needed for activities like reading, sewing and driving. In dry AMD, cells in the macula die. GA is the advanced form of dry AMD. Sirolimus helps prevent inflammation and may therefore help treat GA.
Patients 55 years of age or older with GA due to AMD in both eyes who have a visual acuity between 20/20 and 20/400 in each eye may be eligible for this study.
Participants receive a sirolimus injection in one eye (the study eye) every 3 months. To prepare for the injection, patients receive antibiotic and numbing eye drops, and the eye and the area around it is cleaned with an antiseptic. Patients return to the clinic for follow-up visits at 1 month and 2 months after the first injection, and then every 3 months for up to 2 years. At the 3-month visits, patients have the following tests and procedures:
Condition | Intervention | Phase |
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Age-Related Macular Degeneration |
Drug: Sirolimus |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration |
Estimated Enrollment: | 15 |
Study Start Date: | October 2008 |
Objective:
Age-related macular degeneration (AMD), the leading cause of blindness in people over age 55 in the United States, is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment of central visual acuity. AMD occurs in two general forms, one of which involves choroidal neovascularization (CNV) with subsequent formation of a disciform scar. This is often referred to as the neovascular or wet form. A second form, the subject of this study, is termed dry or atrophic macular degeneration and involves a constellation of clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium (RPE) dropout and geographic atrophy (GA). GA can begin as a thinning of the RPE with involvement of the underlying choriocapillaris and lead subsequently to an atrophic change in the macula. Inflammation may play a role in the pathogenesis of GA. Sirolimus inhibits the production, signaling and activity of many inflammatory factors relevant to the development of GA. Therefore, the objective of this study is to investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA.
Study Population:
Ten participants with bilateral GA associated with AMD, with the potential to replace up to five participants if some fail to reach one year of follow-up.
Design:
In this controlled, unmasked, Phase I/II study, one eye of eligible participants will be randomized to treatment while the fellow eye will be observed. Participants will receive a 20 micro liter (440 micro gram) subconjunctival injection of sirolimus in the study eye at baseline and every two months thereafter. The study will be completed once all partcipants have received two years of study medication and follow-up.
Outcome Measures:
The primary outcome is the rate of change in area of GA, based on masked grading by an external Reading Center, of fundus photography in the study eye and fellow eye at two years compared with baseline. Secondary outcomes will include worsening of best-corrected visual acuity (BCVA) of three or more lines (15 or more letters), changes in area of GA as measured on autofluorescence, changes in drusen volume as measured by optical coherence tomography, as well as changes in drusen area based on masked digital grading of fundus photographs. Safety outcomes will include the number and severity of systemic and ocular toxicities, adverse events and infections.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Catherine Meyerle, M.D./National Eye Institute ) |
Study ID Numbers: | 090008, 09-EI-0008 |
Study First Received: | October 3, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00766649 |
Health Authority: | United States: Federal Government |
Age Related Macular Degeneration (AMD) Geographic Atrophy Sirolimus |
Age-Related Macular Degeneration AMD Geographic Atrophy |
Sirolimus Pathological Conditions, Anatomical Clotrimazole Miconazole Eye Diseases Tioconazole |
Retinal Degeneration Macular Degeneration Atrophy Retinal Diseases Retinal degeneration |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |