NCT00306488

OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration

A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.

Detailed description

Age-related macular Degeneration (AMD), the leading cause of blindness in people over age 55 in the U.S., is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. AMD occurs in two general forms, one of which involves subchoroidal neovascularization with subsequent formation of a disciform scar. A second form, and 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. Geographic atrophy can begin as a thinning of the RPE with involvement of the underlying choriocapillaris and lead subsequently to an atrophic change in the macula. The only therapy for persons with atrophic AMD is an oral supplement containing high doses of antioxidants and zinc, which was tested by the National Eye Institute (NEI) in a large, multicenter, double-masked, placebo-controlled clinical trial with average participant follow-up of about 6 years. This antioxidant therapy was shown to modestly retard the progression of dry AMD from an intermediate stage to the advanced stages and demonstrated the benefit of antioxidant therapy in this disease. In this study, we will evaluate Othera Pharmaceuticals' OT-551 antioxidant eye drop for chronic treatment of the dry form of AMD. This single-center, open-label, study of up to 10 participants with bilateral geographic atrophy is designed to characterize the safety of 0.45 percent concentration of OT-551 eye drops, given 3 times a day, on participants with geographic atrophy area for up to three years. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed.

Conditions

• Geographic Atrophy
• Age-Related Macular Degeneration
• AMD

Interventions

Type	Name	Description
DRUG	OT-551 antioxidant eye drop	0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2006-03-23
• Last updated: 2020-07-14
• Results posted: 2011-07-29

Locations

1 site across 1 country: United States