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Anecortave Acetate in Patients With Open-angle Glaucoma

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 6 mg/mL
Anecortave Acetate Sterile Suspension, 30 mg/mL
Anecortave Acetate Sterile Suspension, 60 mg/mL
Anecortave Acetate Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open-angle, glaucoma

Eligibility Criteria

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

Inclusion Criteria: Patients 18 years of age or older with open-angle glaucoma. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component. Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Other

    Arm Label

    Anecortave Acetate 3 mg Depot

    Anecortave Acetate 15 mg Depot

    Anecortave Acetate 30 mg Depot

    Anecortave Acetate Vehicle

    Arm Description

    Single injection, anterior juxtascleral depot (AJD)

    Single injection, anterior juxtascleral depot (AJD)

    Single injection, anterior juxtascleral depot (AJD)

    Single injection, anterior juxtascleral depot (AJD)

    Outcomes

    Primary Outcome Measures

    Mean change in intraocular pressure at 9 am from baseline

    Secondary Outcome Measures

    Time to treatment failure

    Full Information

    First Posted
    May 1, 2006
    Last Updated
    November 27, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00320203
    Brief Title
    Anecortave Acetate in Patients With Open-angle Glaucoma
    Official Title
    A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 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 is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-angle Glaucoma
    Keywords
    open-angle, glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anecortave Acetate 3 mg Depot
    Arm Type
    Experimental
    Arm Description
    Single injection, anterior juxtascleral depot (AJD)
    Arm Title
    Anecortave Acetate 15 mg Depot
    Arm Type
    Experimental
    Arm Description
    Single injection, anterior juxtascleral depot (AJD)
    Arm Title
    Anecortave Acetate 30 mg Depot
    Arm Type
    Experimental
    Arm Description
    Single injection, anterior juxtascleral depot (AJD)
    Arm Title
    Anecortave Acetate Vehicle
    Arm Type
    Other
    Arm Description
    Single injection, anterior juxtascleral depot (AJD)
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate Sterile Suspension, 6 mg/mL
    Intervention Description
    Single injection, anterior juxtascleral depot (AJD)
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate Sterile Suspension, 30 mg/mL
    Intervention Description
    Single injection, anterior juxtascleral depot (AJD)
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate Sterile Suspension, 60 mg/mL
    Intervention Description
    Single injection, anterior juxtascleral depot (AJD)
    Intervention Type
    Other
    Intervention Name(s)
    Anecortave Acetate Vehicle
    Intervention Description
    Single injection, anterior juxtascleral depot (AJD)
    Primary Outcome Measure Information:
    Title
    Mean change in intraocular pressure at 9 am from baseline
    Time Frame
    Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
    Secondary Outcome Measure Information:
    Title
    Time to treatment failure
    Time Frame
    At time point

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years of age or older with open-angle glaucoma. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Theresa Landry
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Anecortave Acetate in Patients With Open-angle Glaucoma

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