Company decision

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.

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.

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