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

Phase 2

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: OT-551; Drug: vehicle placebo

• Registration Number: NCT00485394
• Lead Sponsor: Othera Pharmaceuticals

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-13
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-31
• Last Update Posted: 2008-04-02
• Primary Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• have a clinical diagnosis of GA in one or both eyes;
• be of non-childbearing potential

Exclusion Criteria

• have GA secondary to any condition other than AMD in the study eye;
• have a BCVA of 20/200 or worse in the non-study eye;
• have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy;
• have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study;
• need to wear contact lenses in the study eye during the study;
• had confounding ocular surgery in the study eye;
• have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	OT-551	OT-551 0.3% ophthalmic solution
3	vehicle placebo	vehicle placebo
2	OT-551	OT-551 0.45% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Change in the area of GA	2 years