Glendale, California 91203

  • related Macular Degeneration

Purpose:

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 2 years


Study summary:

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 in 2 periods (Year 1 and Year 2). Year 1 (Screening/Baseline to Week 52): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio: - Squalamine lactate ophthalmic solution, 0.2% BID (Years 1 and 2) + ranibizumab every 4 weeks (Year 1) and PRN ranibizumab (as needed, Year 2) - Placebo ophthalmic solution BID (Years 1 and 2) + monthly ranibizumab every 4 weeks (Year 1) and PRN ranibizumab (Year 2), based on optical coherence tomography (OCT)-guided re-treatment criteria


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


NCT ID:

NCT02727881


Primary Contact:

Study Director
Avner Ingerman, MD
Ohr Pharmaceutical

Avner Ingerman, MD
Phone: 2126828452 ext. 113
Email: aingerman@ohrpharmaceutical.com


Backup Contact:

Email: sshearn@ohrpharmaceutical.com
Shawn Shearn, MSc.
Phone: 2126828452 ext. 113


Location Contact:

Glendale, California 91203
United States



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Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 04, 2022

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