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

NCT ID: NCT00485394

Last Updated: 2008-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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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

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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

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Age-Related Macular Degeneration

Keywords

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AMD age-related macular degeneration geographic atrophy GA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

OT-551 0.3% ophthalmic solution

Group Type EXPERIMENTAL

OT-551

Intervention Type DRUG

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

2

OT-551 0.45% ophthalmic solution

Group Type EXPERIMENTAL

OT-551

Intervention Type DRUG

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

3

vehicle placebo

Group Type PLACEBO_COMPARATOR

vehicle placebo

Intervention Type DRUG

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

Interventions

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OT-551

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

Intervention Type DRUG

OT-551

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

Intervention Type DRUG

vehicle placebo

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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Othera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Othera Pharmaceuticals, Inc.

Locations

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Mesa, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Beverly Hills, California, United States

Site Status

Oxnard, California, United States

Site Status

Sacramento, California, United States

Site Status

Denver, Colorado, United States

Site Status

Boynton Beach, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Novi, Michigan, United States

Site Status

New York, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Lakewood, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.othera.com

Othera Pharmaceuticals, Inc. website

Other Identifiers

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OT-551-C04

Identifier Type: -

Identifier Source: org_study_id