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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00429936

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 AMD	Drug: Fenretinide	Phase II

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

ChemIDplus related topics:

Fenretinide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

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

Enrollment:	245
Study Start Date:	December 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years to 89 Years
Genders Eligible for Study:	Both

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.

Investigators


Study Chair:	Roger Vogel	Sirion Therapeutics, Inc.

More Information

Responsible Party:	Sirion Therapeutics ( Chief Medical Officer )
Study ID Numbers:	SRFR-001
First Received:	January 30, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00429936
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sirion Therapeutics, Inc.:

Dry Age Related Macular Degeneration

Geographic Atrophy

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Eye Diseases

Retinal Degeneration

Macular Degeneration

Atrophy

Fenretinide

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Anticarcinogenic Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008