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

This study has been completed.
Sponsor:
Collaborator:
ReVision Therapeutics, Inc.
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00429936
First received: January 30, 2007
Last updated: June 21, 2010
Last verified: June 2010

January 30, 2007
June 21, 2010
December 2006
May 2010   (final data collection date for primary outcome measure)
GA lesion progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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: Double Blind (Subject, Caregiver, 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)
Both
50 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00429936
SRFR-001
Yes
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