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Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anecortave Acetate 15 mg sterile suspension
Anecortave Acetate Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, anecortave acetate, wet AMD, age-related macular degeneration, Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 50 years. Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Anecortave Acetate

    Anecortave Acetate Vehicle

    Arm Description

    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

    Outcomes

    Primary Outcome Measures

    Mean change from baseline in logMAR visual acuity score at 12 months

    Secondary Outcome Measures

    Full Information

    First Posted
    January 3, 2003
    Last Updated
    November 27, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00051129
    Brief Title
    Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)
    Official Title
    An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related
    Keywords
    AMD, anecortave acetate, wet AMD, age-related macular degeneration, Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    291 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anecortave Acetate
    Arm Type
    Experimental
    Arm Description
    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
    Arm Title
    Anecortave Acetate Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate 15 mg sterile suspension
    Intervention Description
    0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
    Intervention Type
    Other
    Intervention Name(s)
    Anecortave Acetate Vehicle
    Intervention Description
    Administered as a posterior juxtascleral injection
    Primary Outcome Measure Information:
    Title
    Mean change from baseline in logMAR visual acuity score at 12 months
    Time Frame
    Month 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 50 years. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

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