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

Age-Related Macular Degeneration Clinical Trial

— OMEGA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00485394
• Other study ID #: OT-551-C04
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 11, 2007
• Last updated: March 31, 2008
• Start date: June 2007

Study information

• Verified date: March 2008
• Source: Othera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• OT-551
OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
• OT-551
OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
• vehicle placebo
OT-551 0% ophthalmic solution, 2 drops 4 times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Othera Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the area of GA		2 years	No