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


Trial ID: NCT02727881


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)

Stanford Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS

Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)


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

   - 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


drug: Squalamine lactate ophthalmic solution, 0.2%

drug: Placebo Ophthalmic solution

drug: ranibizumab


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305