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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Othera Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Othera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00485394
First received: June 11, 2007
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Drug: OT-551
Drug: vehicle placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Othera Pharmaceuticals:

Primary Outcome Measures:
  • Change in the area of GA [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: June 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485394

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

Additional Information:
No publications provided

Responsible Party: Alison Brown, Othera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00485394     History of Changes
Other Study ID Numbers: OT-551-C04
Study First Received: June 11, 2007
Last Updated: March 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Othera Pharmaceuticals:
AMD
age-related macular degeneration
geographic atrophy
GA

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014