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

Sponsor

Othera Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00485394

Collaborator

(none)

198

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Drug: OT-551 Drug: OT-551 Drug: vehicle placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 OT-551 0.3% ophthalmic solution	Drug: OT-551 OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
Experimental: 2 OT-551 0.45% ophthalmic solution	Drug: OT-551 OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
Placebo Comparator: 3 vehicle placebo	Drug: vehicle placebo OT-551 0% ophthalmic solution, 2 drops 4 times daily

Arm

Intervention/Treatment

Experimental: 1

OT-551 0.3% ophthalmic solution

Drug: OT-551

OT-551 0.3% ophthalmic solution, 2 drops 4 times daily

Experimental: 2

OT-551 0.45% ophthalmic solution

Drug: OT-551

OT-551 0.45% ophthalmic solution, 2 drops 4 times daily

Placebo Comparator: 3

vehicle placebo

Drug: vehicle placebo

OT-551 0% ophthalmic solution, 2 drops 4 times daily

Outcome Measures

Primary Outcome Measures

Change in the area of GA [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	City	State	Country
1	Mesa	Arizona	United States
2	Tucson	Arizona	United States
3	Beverly Hills	California	United States
4	Oxnard	California	United States
5	Sacramento	California	United States
6	Denver	Colorado	United States
7	Boynton Beach	Florida	United States
8	Miami	Florida	United States
9	Indianapolis	Indiana	United States
10	Novi	Michigan	United States
11	New York	New York	United States
12	Charlotte	North Carolina	United States
13	Cleveland	Ohio	United States
14	Lakewood	Ohio	United States
15	Portland (#2)	Oregon	United States
16	Portland	Oregon	United States
17	Dallas	Texas	United States
18	Houston	Texas	United States