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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT02727881

Run by

Ohr Pharmaceutical Inc.

People needed

230

Starts

2016-04-12

Expected to finish

2017-12-01

Last updated by the study team

2017-04-27

Who can join

Age: 50 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Tucson, Arizona, United States
• Investigational Site — Arcadia, California, United States
• Investigational Site — Beverly Hills, California, United States
• Investigational Site — Campbell, California, United States
• Investigational Site — Fullerton, California, United States
• Investigational Site — Glendale, California, United States
• Investigational Site — Glendora, California, United States
• Investigational Site — La Jolla, California, United States
• Investigational Site — Laguna Hills, California, United States
• Investigational Site — Loma Linda, California, United States
• Investigational Site — Los Angeles, California, United States
• Investigational Site — Oceanside, California, United States
• Investigational Site — Orange, California, United States
• Investigational Site — Palm Desert, California, United States
• Investigational Site — Palo Alto, California, United States
• Investigational Site — Pasadena, California, United States
• Investigational Site — Poway, California, United States
• Investigational Site — Redlands, California, United States
• Investigational Site — Sacramento, California, United States
• Investigational Site — Bridgeport, Connecticut, United States
• Investigational Site — Hamden, Connecticut, United States
• Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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