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Geographic Atrophy Treatment Evaluation (GATE)
This study is currently recruiting participants.
Verified by Alcon Research, April 2009
First Received: April 27, 2009   Last Updated: April 28, 2009   History of Changes
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00890097
  Purpose

Randomized, multi-center, placebo-controlled study evaluating AL-8309B as a topical ocular treatment for geographic atrophy secondary to AMD


Condition Intervention Phase
Geographic Atrophy
Age Related Macular Degeneration
Drug: 1.75% AL-8309B Ophthalmic Solution
Drug: 1.0% AL-8309B Ophthalmic Solution
Drug: AL-8309B Ophthalmic Solution Vehicle
Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean annualized atrophic lesion growth [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 550
Study Start Date: April 2009
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1.75% AL-8309B Ophthalmic Solution
Drug: 1.75% AL-8309B Ophthalmic Solution
One drop 2x daily
2: Experimental
1.0% AL-8309B Ophthalmic Solution
Drug: 1.0% AL-8309B Ophthalmic Solution
One drop 2x daily
3: Placebo Comparator
AL-8309B Ophthalmic Solution Vehicle
Drug: AL-8309B Ophthalmic Solution Vehicle
One drop 2x daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be willing to give written informed consent, make the required study visits, and follow instructions.
  • Patient must be 55 years of age or older.
  • Patient must state the ability to administer eye drops or have a caretaker to administer the eye drops.
  • The study eye must have:

    • A well-demarcated area of atrophy secondary to age-related macular degeneration
    • If the lesion is multifocal, at least one focal lesion must be equal to or larger than 1.25 mm2 [0.5 Disc Areas (DA)]
    • The total lesion size must be less than or equal to 20 mm2 [8 (DA)].
  • Presence of hyperautofluorescence adjacent to an area of atrophy.
  • No evidence of CNV
  • A best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better.
  • Clear ocular media and adequate pupillary dilation to permit good quality photographic imaging.
  • There are no inclusion criteria for the fellow eye.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women.
  • Pre-menopausal women of child-bearing potential not using adequate contraception.
  • Ocular disease in the study eye that in the opinion of the Investigator may confound assessment of the retina or affect central vision, other than non-exudative AMD [e.g., branch retinal vein occlusion (BCVO), diabetic retinopathy, uveitis].
  • History of cataract surgery in either eye within the past three (3) months of screening (Visit 1).
  • History or evidence of serious ocular trauma or intraocular surgery (e.g. Lasik, keratoplasty) in either eye within the past six (6) months of screening (Visit 1).
  • Evidence of significant uncontrolled comorbidity or condition with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease) 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 (Visit 1).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890097

Contacts
Contact: Alcon Call Center 1-888-451-3937 medical.information@alconlabs.com

Locations
United States, Texas
Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Contact: Guy Simpson, Pharm. D.     817-615-2293     guy.simpson@alconlabs.com    
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( Guy Simpson\Asst. Director, Clinical Trial Management )
Study ID Numbers: C-08-36
Study First Received: April 27, 2009
Last Updated: April 28, 2009
ClinicalTrials.gov Identifier: NCT00890097     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Geographic Atrophy
AMD
age related macular degeneration
Geographic Atrophy Secondary amd

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Eye Diseases
Neoplasm Metastasis
Retinal Degeneration
Macular Degeneration
Atrophy
Retinal Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009