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

March 31, 2008 updated by: Othera Pharmaceuticals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Oxnard, California, United States
      • Sacramento, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Miami, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Michigan
      • Novi, Michigan, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Lakewood, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
      • Portland (#2), Oregon, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Drug: OT-551
OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
Experimental: 2
OT-551 0.45% ophthalmic solution
Drug: OT-551
OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the area of GA
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Othera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-551-C04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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