NCT00429936

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

3.4 years

First QC Date

January 30, 2007

Last Update Submit

June 21, 2010

Conditions

Geographic AtrophyDry Age Related Macular Degeneration

Keywords

Dry Age Related Macular DegenerationGeographic Atrophy

Outcome Measures

Primary Outcomes (1)

  • GA lesion progression

    1 year

Study Arms (3)

100 mg fenretinide softgel capsules

ACTIVE COMPARATOR

Three (3) 100-mg fenretinide softgel capsules

Drug: Fenretinide

Fenretinide and placebo softgel capsules

ACTIVE COMPARATOR

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

Drug: Fenretinide

Placebo softgel capsules

PLACEBO COMPARATOR

Three (3) placebo softgel capsules

Drug: Fenretinide

Interventions

FenretinideDRUG

Once daily 30 minutes after the evening meal for 24 months

100 mg fenretinide softgel capsulesFenretinide and placebo softgel capsulesPlacebo softgel capsules

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males or females, 50 to 89 years of age
  • must have GA from AMD in one or both eyes

You may not qualify if:

  • GA due to any disease other than AMD (eg, drug-induced)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33331670DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Roger Vogel, MD

    ReVision Therapeutics Advisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-06