Status:
COMPLETED
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Lead Sponsor:
Alcon Research
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Following a single administration, patients will be followed for 6 months postinjection.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00992563
Start Date
June 1 2010
End Date
May 1 2011
Last Update
July 18 2014
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