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

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