Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306488
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2006-03-22
Brief Title:
OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 045 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 US 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 andor 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 045 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
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 045 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-EI-0116 | OTHER | National Eye Institute | None |