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

Study Overview
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Brief Summary
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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
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Following a single administration, patients will be followed for 6 months postinjection.

Official Title
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A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: AL-39324 ophthalmic suspension
* Drug: Ranibizumab 10 mg/mL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-39324 Concentration Level A<br>AL-39324 ophthalmic suspension, single intravitreal injection | Drug: AL-39324 ophthalmic suspension<br> <br> |
| Experimental: AL-39324 Concentration Level B<br>AL-39324 ophthalmic suspension, single intravitreal injection | Drug: AL-39324 ophthalmic suspension<br> <br> |
| Experimental: AL-39324 Concentration Level C<br>AL-39324 ophthalmic suspension, single intravitreal injection | Drug: AL-39324 ophthalmic suspension<br> <br> |
| Experimental: AL-39324 Concentration Level D<br>AL-39324 ophthalmic suspension, single intravitreal injection | Drug: AL-39324 ophthalmic suspension<br> <br> |
| Experimental: AL-39324 Concentration Level E<br>AL-39324 ophthalmic suspension, single intravitreal injection | Drug: AL-39324 ophthalmic suspension<br> <br> |
| Active Comparator: Lucentis<br>Ranibizumab 10 mg/mL solution, single intravitreal injection | Drug: Ranibizumab 10 mg/mL<br> <br> * Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of targeted adverse events occurring in the study eye |  | Up to Day 7 after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in central foveal thickness (CFT) at Month 1 |  | Baseline (Day 0), Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet age-related macular degeneration, exudative