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

NCT ID: NCT00429936

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Geographic Atrophy Dry Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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100 mg fenretinide softgel capsules

Three (3) 100-mg fenretinide softgel capsules

Group Type ACTIVE_COMPARATOR

Fenretinide

Intervention Type DRUG

Once daily 30 minutes after the evening meal for 24 months

Fenretinide and placebo softgel capsules

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

Group Type ACTIVE_COMPARATOR

Fenretinide

Intervention Type DRUG

Once daily 30 minutes after the evening meal for 24 months

Placebo softgel capsules

Three (3) placebo softgel capsules

Group Type PLACEBO_COMPARATOR

Fenretinide

Intervention Type DRUG

Once daily 30 minutes after the evening meal for 24 months

Interventions

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Fenretinide

Once daily 30 minutes after the evening meal for 24 months

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ReVision Therapeutics, Inc.

OTHER

Sponsor Role collaborator

Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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ReVision Therapeutics, Inc.

Principal Investigators

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Roger Vogel, MD

Role: STUDY_DIRECTOR

ReVision Therapeutics Advisor

References

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Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.

Reference Type DERIVED
PMID: 33331670 (View on PubMed)

Other Identifiers

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SRFR-001

Identifier Type: -

Identifier Source: org_study_id

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