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NCT00429936 Clinical Trial

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

Geographic Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00429936
Other study ID # SRFR-001
Secondary ID
Status Completed
Phase Phase 2
First received January 30, 2007
Last updated June 21, 2010
Start date December 2006
Est. completion date May 2010

Study information
Verified date June 2010
Source Sirion Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 89 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fenretinide
Once daily 30 minutes after the evening meal for 24 months

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Sirion Therapeutics, Inc. ReVision Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary GA lesion progression 1 year No
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