Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
June 21, 2010 updated by: Sirion Therapeutics, Inc.
A Phase II Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects With Age-Related Macular Degeneration
The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
245
Phase
- Phase 2
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
50 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males or females, 50 to 89 years of age
- must have GA from AMD in one or both eyes
Exclusion Criteria:
- GA due to any disease other than AMD (eg, drug-induced)
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 |
|---|---|
|
Active Comparator: 100 mg fenretinide softgel capsules
Three (3) 100-mg fenretinide softgel capsules
|
Once daily 30 minutes after the evening meal for 24 months
|
|
Active Comparator: Fenretinide and placebo softgel capsules
One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules
|
Once daily 30 minutes after the evening meal for 24 months
|
|
Placebo Comparator: Placebo softgel capsules
Three (3) placebo softgel capsules
|
Once daily 30 minutes after the evening meal for 24 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
GA lesion progression
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Roger Vogel, MD, ReVision Therapeutics Advisor
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.
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
December 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
January 30, 2007
First Submitted That Met QC Criteria
January 31, 2007
First Posted (Estimate)
February 1, 2007
Study Record Updates
Last Update Posted (Estimate)
June 22, 2010
Last Update Submitted That Met QC Criteria
June 21, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRFR-001
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.