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

Phase 2

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: AL-39324 ophthalmic suspension; Drug: Ranibizumab 10 mg/mL

• Registration Number: NCT00992563
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Study Start: 2010-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-16
• Disposition First Submitted QC: 2014-07-16
• Last Update Submitted: 2014-07-16
• Disposition First Posted: 2014-07-18
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-39324 Concentration Level B	AL-39324 ophthalmic suspension	AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level A	AL-39324 ophthalmic suspension	AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level E	AL-39324 ophthalmic suspension	AL-39324 ophthalmic suspension, single intravitreal injection
Lucentis	Ranibizumab 10 mg/mL	Ranibizumab 10 mg/mL solution, single intravitreal injection
AL-39324 Concentration Level D	AL-39324 ophthalmic suspension	AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level C	AL-39324 ophthalmic suspension	AL-39324 ophthalmic suspension, single intravitreal injection

Primary Outcome Measures

Name	Time	Method
Incidence of targeted adverse events occurring in the study eye	Up to Day 7 after injection

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in central foveal thickness (CFT) at Month 1	Baseline (Day 0), Month 1