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

Phase 2

Completed

• Conditions: Geographic Atrophy; Dry Age Related Macular Degeneration
• Interventions: Drug: Fenretinide

• Registration Number: NCT00429936
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-21
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenretinide and placebo softgel capsules	Fenretinide	One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules
Placebo softgel capsules	Fenretinide	Three (3) placebo softgel capsules
100 mg fenretinide softgel capsules	Fenretinide	Three (3) 100-mg fenretinide softgel capsules

Primary Outcome Measures

Name	Time	Method
GA lesion progression	1 year