Overview

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

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ohr Pharmaceutical Inc.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Ranibizumab
Squalamine
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