WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Willing to give written informed consent, make the required study visits and follow instructions;

• The study eye:

• must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;

• lesion must be no larger than 30 mm2;

• must have edema measuring greater than 340 μm;

• must have a visual score between 73 and 34 letters, inclusive;

• must be able to have clear picture taken of the back of the eye;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• The study eye must not have been treated for exudative AMD previously;

• The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;

• The study eye must not have uncontrolled glaucoma;

• The study eye must not be missing a lens;

• Must not be taking any medication that is toxic to the lens;

• Must not be taking oral or ocular corticosteroids;

• Must not have an unstable or progressive condition that would interfere with study visits;

• Must not have allergies to any component of the test article or sensitivity to fluorescein dye;

• If female, must not be pregnant or nursing and must agree to adequate birth control;

• Must not be participating in another drug or device study within 30 days of screening for this study;

• Other protocol-defined exclusion criteria may apply.