©2024 Stanford Medicine
Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
Recruiting
Trial ID: NCT02727881
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)
Stanford Investigator(s)
Theodore Leng, MD, FACS
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
Eligibility
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
Intervention(s):
drug: Squalamine lactate ophthalmic solution, 0.2%
drug: Placebo Ophthalmic solution
drug: ranibizumab
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305