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

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ClinicalTrials.gov Identifier: NCT00429936
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : June 22, 2010
Sponsor:
Collaborator:
ReVision Therapeutics, Inc.
Information provided by:
Sirion Therapeutics, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Geographic Atrophy Dry Age Related Macular Degeneration Drug: Fenretinide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 100 mg fenretinide softgel capsules
Three (3) 100-mg fenretinide softgel capsules
Drug: Fenretinide
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
Drug: Fenretinide
Once daily 30 minutes after the evening meal for 24 months
Placebo Comparator: Placebo softgel capsules
Three (3) placebo softgel capsules
Drug: Fenretinide
Once daily 30 minutes after the evening meal for 24 months



Primary Outcome Measures :
  1. GA lesion progression [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429936


Sponsors and Collaborators
Sirion Therapeutics, Inc.
ReVision Therapeutics, Inc.
Investigators
Study Director: Roger Vogel, MD ReVision Therapeutics Advisor

Responsible Party: ReVision Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00429936     History of Changes
Other Study ID Numbers: SRFR-001
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Sirion Therapeutics, Inc.:
Dry Age Related Macular Degeneration
Geographic Atrophy

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