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Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429936
First Posted: February 1, 2007
Last Update Posted: June 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ReVision Therapeutics, Inc.
Information provided by:
Sirion Therapeutics, Inc.
January 30, 2007
February 1, 2007
June 22, 2010
December 2006
May 2010   (Final data collection date for primary outcome measure)
GA lesion progression [ Time Frame: 1 year ]
Not Provided
Complete list of historical versions of study NCT00429936 on ClinicalTrials.gov Archive Site
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Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Geographic Atrophy
  • Dry Age Related Macular Degeneration
Drug: Fenretinide
Once daily 30 minutes after the evening meal for 24 months
  • Active Comparator: 100 mg fenretinide softgel capsules
    Three (3) 100-mg fenretinide softgel capsules
    Intervention: Drug: Fenretinide
  • Active Comparator: Fenretinide and placebo softgel capsules
    One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules
    Intervention: Drug: Fenretinide
  • Placebo Comparator: Placebo softgel capsules
    Three (3) placebo softgel capsules
    Intervention: Drug: Fenretinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
May 2010
May 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00429936
SRFR-001
Yes
Not Provided
Not Provided
ReVision Therapeutics, Inc.
Sirion Therapeutics, Inc.
ReVision Therapeutics, Inc.
Study Director: Roger Vogel, MD ReVision Therapeutics Advisor
Sirion Therapeutics, Inc.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP