Age-Related Macular Degeneration
Conditions
Brief summary
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
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.
Interventions
DRUGranibizumab
ranibizumab intravitreal injection
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
DRUGPlacebo Ophthalmic Solution
Placebo Ophthalmic Solution, administered BID
Sponsors
Ohr Pharmaceutical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed