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

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).

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Key information

Conditions

Geographic Atrophy Dry Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fenretinide

Drug

Once daily 30 minutes after the evening meal for 24 months

Primary outcomes

GA lesion progression

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sirion Therapeutics, Inc.

Industry

Collaborators

ReVision Therapeutics, Inc.

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Feb 1, 2007
Registry last updated: Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed