Geographic Atrophy Treatment Evaluation

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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.