Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    245
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).
Study Started
Dec 31
2006
Primary Completion
May 31
2010
Study Completion
May 31
2010
Last Update
Jun 22
2010
Estimate

Drug Fenretinide

Once daily 30 minutes after the evening meal for 24 months

100 mg fenretinide softgel capsules Active Comparator

Three (3) 100-mg fenretinide softgel capsules

Fenretinide and placebo softgel capsules Active Comparator

One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules

Placebo softgel capsules Placebo Comparator

Three (3) placebo softgel capsules

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)
No Results Posted