search
Back to results

Geographic Atrophy Treatment Evaluation (GATE)

Primary Purpose

Geographic Atrophy, Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-8309B Ophthalmic Solution
AL-8309B Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Willing to give written informed consent, make required study visits, and follow instructions.
  • Able to administer eye drops or have a caretaker to administer the eye drops.
  • Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, nursing, or not using adequate contraception.
  • Ocular disease in the study eye, other than non-exudative AMD.
  • History of cataract surgery in either eye within the past 3 months of screening.
  • History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
  • Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
  • Participation in an investigational drug or device study within 30 days of screening.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    AL-8309B 1.0%

    AL-8309B 1.75%

    Vehicle

    Arm Description

    AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months

    AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months

    AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months

    Outcomes

    Primary Outcome Measures

    Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
    The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2009
    Last Updated
    June 4, 2014
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00890097
    Brief Title
    Geographic Atrophy Treatment Evaluation
    Acronym
    GATE
    Official Title
    The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Treatment ineffective
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to 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, Age-Related Macular Degeneration
    Keywords
    Geographic Atrophy, GA, Age-Related Macular Degeneration, AMD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    772 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-8309B 1.0%
    Arm Type
    Experimental
    Arm Description
    AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
    Arm Title
    AL-8309B 1.75%
    Arm Type
    Experimental
    Arm Description
    AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
    Intervention Type
    Drug
    Intervention Name(s)
    AL-8309B Ophthalmic Solution
    Intervention Type
    Drug
    Intervention Name(s)
    AL-8309B Vehicle
    Intervention Description
    Inactive ingredients used as placebo comparator
    Primary Outcome Measure Information:
    Title
    Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
    Description
    The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
    Time Frame
    Baseline, up to Month 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing to give written informed consent, make required study visits, and follow instructions. Able to administer eye drops or have a caretaker to administer the eye drops. Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant, nursing, or not using adequate contraception. Ocular disease in the study eye, other than non-exudative AMD. History of cataract surgery in either eye within the past 3 months of screening. History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening. Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely. Participation in an investigational drug or device study within 30 days of screening. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sally Scheib, Sr. Clinical Lead
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Geographic Atrophy Treatment Evaluation

    We'll reach out to this number within 24 hrs