Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

Study Overview
=================
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

Official Title
-----------------
OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Squalamine lactate ophthalmic solution, 0.2%
* Drug: Placebo Ophthalmic solution
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) 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 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Squalamine solution, 0.2% BID<br>Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks | Drug: Squalamine lactate ophthalmic solution, 0.2%<br>* Squalamine lactate ophthalmic solution, 0.2%<br>* Other names: active;Drug: ranibizumab<br>* ranibizumab<br>* Other names: Lucentis;|
| Placebo Comparator: Placebo solution BID<br>Placebo ophthalmic solution BID + ranibizumab every 4 weeks | Drug: Placebo Ophthalmic solution<br>* Placebo Ophthalmic solution<br>* Other names: placebo;Drug: ranibizumab<br>* ranibizumab<br>* Other names: Lucentis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional change in visual acuity | 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 | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional changes in visual acuity | 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 | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, CNV, choroidal neovascularization, retinal eye disease