Status:
TERMINATED
Geographic Atrophy Treatment Evaluation
Lead Sponsor:
Alcon Research
Conditions:
Geographic Atrophy
Age-Related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE3
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) sec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
772 Patients enrolled
Trial Details
Trial ID
NCT00890097
Start Date
April 1 2009
End Date
May 1 2012
Last Update
July 3 2014
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