Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration

Study Overview
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Brief Summary
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The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.

Detailed Description
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Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.

Official Title
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A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
* Drug: Placebo Ophthalmic Solution
* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years of age or older A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT) Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol Exclusion Criteria: Neovascularization secondary to any other condition than AMD in the study eye Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea PED without associated subretinal fluid and/or cystic retinal changes Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease) Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution | Drug: Placebo Ophthalmic Solution<br>* Placebo Ophthalmic Solution, administered BID<br>* Other names: Placebo;Drug: ranibizumab<br>* ranibizumab intravitreal injection<br>* Other names: Lucentis®;|
| Active Comparator: Active<br>Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2% | Drug: Squalamine Lactate Ophthalmic Solution, 0.2%<br>* Squalamine Lactate Ophthalmic Solution, 0.2% administered BID<br>* Other names: Squalamine;Drug: ranibizumab<br>* ranibizumab intravitreal injection<br>* Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration |  | 6 months |