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Michael J Elman, David M Brown, Peter K Kaiser, Jason S Slakter; Clinical Study of Squalamine Lactate Ophthalmic Solution 0.2% in Combination with Ranibizumab Compared to Ranibizimab Monotherapy in Treatment Naive Neovascular Age-Related Macular DegenerationClinical Study of Squalamine Lactate Ophthalmic Solution 0.2% in Combination with Ranibizumab Compared to Ranibizimab Monotherapy in Treatment Naive Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4950.
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© ARVO (1962-2015); The Authors (2016-present)
We performed a prospective clinical trial to determine if squalamine lactate ophthalmic solution, 0.2% (Squalamine) used in combination with ranibizumab provides better outcomes than ranibizumab monotherapy in patients with treatment naive exudative AMD.
Prospective, randomized, double-masked, multi-center trial of treatment naïve subjects with newly diagnosed neovascular AMD. Entry criteria included best corrected visual acuity of 24-73 ETDRS letters (20/320 – 20/40 Snellen equivalent), total lesion size up to 30.5 square millimeters (12 MPS disc areas), any type of CNV, but any occult CNV, if present, must measure less than 10 square millimeters on fluorescein angiography. Subjects were randomized 1:1 to receive either Squalamine drops or placebo drops twice a day for the full nine-month study duration. All subjects received monthly intravitreal injections of ranibizumab. The primary efficacy endpoint is a measure of visual acuity gain at week 36.
Over 200 subjects were enrolled in the study. Results of visual acuity and safety outcomes will be reported.
The results of this trial will provide data regarding the potential of Squalamine, a topical, small molecule, multi-target angiogenesis inhibitor, to improve outcomes when used in combination with anti-VEGF injections.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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