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

Trial ID or NCT#

NCT02727881

Status

recruiting iconRECRUITING

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 approximately 9 months to primary endpoint

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)

Eligibility Criteria

Ages Eligible for Study: 50 Years to 110 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)

View on ClinicalTrials.gov