Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 10:58 AM
Study NCT ID:
NCT00485394
Status:
UNKNOWN
Last Update Posted:
2008-04-02
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
Sponsor:
Othera Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Masked, Dose-Ranging, Multi-Center, Phase II Study Comparing the Safety and Efficacy of OT-551 With Placebo to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
OMEGA
Brief Summary:
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.
Detailed Description:
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.
Study Oversight
Has Oversight DMC:
True
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?: