Geographic Atrophy Treatment Evaluation (GATE)

This study has been terminated.
(Treatment ineffective)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00890097
First received: April 27, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Geographic Atrophy
Age-Related Macular Degeneration
Drug: AL-8309B Ophthalmic Solution
Drug: AL-8309B Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging [ Time Frame: Baseline, up to Month 30 ] [ Designated as safety issue: No ]
    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.


Enrollment: 772
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Drug: AL-8309B Vehicle
Inactive ingredients used as placebo comparator

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890097

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sally Scheib, Sr. Clinical Lead Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00890097     History of Changes
Other Study ID Numbers: C-08-36
Study First Received: April 27, 2009
Results First Received: June 4, 2014
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Geographic Atrophy
GA
Age-Related Macular Degeneration
AMD

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014