Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
- Conditions
- Age-related Macular Degeneration
- Interventions
- Drug: Placebo Ophthalmic solution
- Registration Number
- NCT02727881
- Lead Sponsor
- Ohr Pharmaceutical Inc.
- Brief Summary
A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint
- Detailed Description
Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months
(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio:
* Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
* Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 230
- Age ≥ 50 years
- A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
- Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
- Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)
- 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
- Pigment epithelial detachment (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo solution BID Placebo Ophthalmic solution Placebo ophthalmic solution BID + ranibizumab every 4 weeks Placebo solution BID ranibizumab Placebo ophthalmic solution BID + ranibizumab every 4 weeks Squalamine solution, 0.2% BID Squalamine lactate ophthalmic solution, 0.2% Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks Squalamine solution, 0.2% BID ranibizumab Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
- Primary Outcome Measures
Name Time Method Functional change in visual acuity 9 months Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
- Secondary Outcome Measures
Name Time Method Functional changes in visual acuity 9 months Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Madison, Wisconsin, United States