Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohr Pharmaceutical Inc.
• Collaborator: Cumberland Valley Retina Consultants, PC
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Ranibizumab; Squalamine

Criteria

Inclusion Criteria:

• Eyes with treatment naïve, center involving macular edema secondary to BRVO, HRVO or CRVO in patients of at least 40 years of age

• Macular edema of 1-4 months duration prior to the baseline visit

• Best corrected baseline ETDRS visual acuity of 20/40 to 20/320 Snellen equivalent using the 4 meter testing method

• Baseline CST greater than or equal to 325uM using SD-OCT imaging

• Less than 50% foveal capillary ring disruption as defined by fluorescein angiography (FA)

• Absence of dense intraretinal or subretinal hemorrhage and or lipid through the foveal center

• Absence of subfoveal fibrosis or hyperpigmentation.

Exclusion Criteria:

• Eyes with ocular pathology other than RVO related macular edema such as clinically significant cataract or media opacity, diabetic retinopathy, macular degeneration, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or intraocular tumor

• Intraocular surgery within 6 months prior to baseline

• Two-plus or greater afferent pupillary defect (APD) in the study eye

• Likelihood of evidence driven indication for peripheral scatter photocoagulation within 6 months of recruitment

• History of previous intravitreal pharmacologic treatment of any kind in the study eye

• History of previous retinal laser photocoagulation of any kind in the study eye

• History of intravitreal anti-VEGF therapy in the fellow eye within 6 months prior to baseline

• Any evidence of baseline ocular neovascularization such as disc neovascularization, preretinal neovascularization, iris or angle neovascularization in the study eye

• Eyes that have shown spontaneous improvement within the preceding 3 months defined as an improvement of best corrected visual acuity of greater than 15 ETDRS letters or thinning of the CST on OCT of greater than 20%