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

Primary Purpose

Geographic Atrophy, Dry Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fenretinide
Sponsored by
Sirion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Dry Age Related Macular Degeneration, Geographic Atrophy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    100 mg fenretinide softgel capsules

    Fenretinide and placebo softgel capsules

    Placebo softgel capsules

    Arm Description

    Three (3) 100-mg fenretinide softgel capsules

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

    Three (3) placebo softgel capsules

    Outcomes

    Primary Outcome Measures

    GA lesion progression

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2007
    Last Updated
    June 21, 2010
    Sponsor
    Sirion Therapeutics, Inc.
    Collaborators
    ReVision Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00429936
    Brief Title
    Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sirion Therapeutics, Inc.
    Collaborators
    ReVision Therapeutics, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Geographic Atrophy, Dry Age Related Macular Degeneration
    Keywords
    Dry Age Related Macular Degeneration, Geographic Atrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    245 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    100 mg fenretinide softgel capsules
    Arm Type
    Active Comparator
    Arm Description
    Three (3) 100-mg fenretinide softgel capsules
    Arm Title
    Fenretinide and placebo softgel capsules
    Arm Type
    Active Comparator
    Arm Description
    One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules
    Arm Title
    Placebo softgel capsules
    Arm Type
    Placebo Comparator
    Arm Description
    Three (3) placebo softgel capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Fenretinide
    Intervention Description
    Once daily 30 minutes after the evening meal for 24 months
    Primary Outcome Measure Information:
    Title
    GA lesion progression
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roger Vogel, MD
    Organizational Affiliation
    ReVision Therapeutics Advisor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33331670
    Citation
    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:CD013154. doi: 10.1002/14651858.CD013154.pub2.
    Results Reference
    derived

    Learn more about this trial

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

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