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

Phase 2

Withdrawn

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Placebo Ophthalmic Solution; Drug: Squalamine Lactate Ophthalmic Solution, 0.2%; Drug: ranibizumab

• Registration Number: NCT02511613
• Lead Sponsor: Ohr Pharmaceutical Inc.

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Ophthalmic Solution	Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
Placebo	ranibizumab	Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
Active	Squalamine Lactate Ophthalmic Solution, 0.2%	Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
Active	ranibizumab	Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Houston, Texas, United States