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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:
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
History of Changes
  Purpose

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 Intervention Phase
Geographic Atrophy
Dry Age Related Macular Degeneration
 Drug: Fenretinide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sirion Therapeutics, Inc.:

Primary Outcome Measures:
  • GA lesion progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429936

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

No publications provided

Responsible Party: ReVision Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00429936     History of Changes
Other Study ID Numbers: SRFR-001
Study First Received: January 30, 2007
Last Updated: June 21, 2010
Health Authority: United States: Food and Drug Administration

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
 Fenretinide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013