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Geographic Atrophy Treatment Evaluation (GATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00890097
Recruitment Status : Terminated (Treatment ineffective)
First Posted : April 29, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE April 27, 2009
First Posted Date  ICMJE April 29, 2009
Results First Submitted Date  ICMJE June 4, 2014
Results First Posted Date  ICMJE July 3, 2014
Last Update Posted Date July 3, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging [ Time Frame: Baseline, up to Month 30 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
Mean annualized atrophic lesion growth [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
Visual acuity [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Geographic Atrophy Treatment Evaluation
Official Title  ICMJE The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Geographic Atrophy
  • Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: AL-8309B Ophthalmic Solution
  • Drug: AL-8309B Vehicle
    Inactive ingredients used as placebo comparator
Study Arms  ICMJE
  • Experimental: AL-8309B 1.0%
    AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
    Intervention: Drug: AL-8309B Ophthalmic Solution
  • Experimental: AL-8309B 1.75%
    AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
    Intervention: Drug: AL-8309B Ophthalmic Solution
  • Placebo Comparator: Vehicle
    AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
    Intervention: Drug: AL-8309B Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00890097
Other Study ID Numbers  ICMJE C-08-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alcon Research
Original Responsible Party Guy Simpson\Asst. Director, Clinical Trial Management, Alcon Research
Current Study Sponsor  ICMJE Alcon Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sally Scheib, Sr. Clinical Lead Alcon Research
PRS Account Alcon Research
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP