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

Primary Purpose

Age-Related Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OT-551
OT-551
vehicle placebo
Sponsored by
Othera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, age-related macular degeneration, geographic atrophy, GA

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

OT-551 0.3% ophthalmic solution

OT-551 0.45% ophthalmic solution

vehicle placebo

Outcomes

Primary Outcome Measures

Change in the area of GA

Secondary Outcome Measures

Full Information

First Posted
June 11, 2007
Last Updated
March 31, 2008
Sponsor
Othera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00485394
Brief Title
The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Othera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, age-related macular degeneration, geographic atrophy, GA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
OT-551 0.3% ophthalmic solution
Arm Title
2
Arm Type
Experimental
Arm Description
OT-551 0.45% ophthalmic solution
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
vehicle placebo
Intervention Type
Drug
Intervention Name(s)
OT-551
Intervention Description
OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
Intervention Type
Drug
Intervention Name(s)
OT-551
Intervention Description
OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
Intervention Type
Drug
Intervention Name(s)
vehicle placebo
Intervention Description
OT-551 0% ophthalmic solution, 2 drops 4 times daily
Primary Outcome Measure Information:
Title
Change in the area of GA
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
City
Mesa
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Oxnard
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Boynton Beach
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Novi
State/Province
Michigan
Country
United States
City
New York
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Lakewood
State/Province
Ohio
Country
United States
City
Portland (#2)
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.othera.com
Description
Othera Pharmaceuticals, Inc. website

Learn more about this trial

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

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