Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
Retinal Vein Occlusion, Macular Edema
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion
Eligibility 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%
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Squalamine and ranibizumab to Week 10
Continue Squalamine, ranibizumab PRN
Stop Squalamine, ranibizumab PRN
All eyes received an initial 10 week mandatory loading period of topical Squalamine Lactate Ophthalmic Solution, 0.2% therapy. All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. Randomize at Week 10 to 2 different groups - Squalamine and No Squalamine, continue PRN ranibizumab in both groups
Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN