NCT00485394

The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Othera Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	OT-551	OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
DRUG	OT-551	OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
DRUG	vehicle placebo	OT-551 0% ophthalmic solution, 2 drops 4 times daily

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-02-01
• First posted: 2007-06-13
• Last updated: 2008-04-02

Locations

17 sites across 1 country: United States