Clinical trial NCT00485394: The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: AMD
age-related macular degeneration
geographic atrophy
GA
Lead sponsor: Othera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 198
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change in the area of GA
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Novi
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Lakewood
country: United States
state: Ohio
city: Portland (#2)
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References: