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Jason S Slakter, Thomas A Ciulla, Michael J Elman, Lawrence J Singerman, Glenn Stoller, Peter K Kaiser, Irach B Taraporewala, Sam Backenroth; Final Results from a Phase 2 Study of Squalamine Lactate Ophthalmic Solution 0.2% (OHR-102) in the Treatment of Neovascular Age-related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4805.
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To determine if topical OHR-102 administered BID in combination with Ranibizumab (RBZ) PRN can safely improve visual outcomes and reduce treatment frequency of RBZ compared to RBZ PRN monotherapy in patients with treatment naïve neovascular AMD.
Phase 2, prospective, randomized, double-masked, placebo-controlled, multicenter study in treatment naïve patients with CNV due to AMD measuring < 12 disc areas, OCT central subfield > 300 microns with subretinal fluid or cystoid macular edema, any lesion composition, and BCVA of 20/40 to 20/320. Diabetics without diabetic retinopathy were included. All patients received RBZ at baseline and randomized 1:1 to topical OHR-102 BID (combination group) or placebo vehicle solution BID (monotherapy group). Patients were followed monthly for 9 months. Retreatment with RBZ was performed if OCT demonstrated cystoid macular edema, intraretinal/subretinal fluid, or RPE elevation.
A total of 142 patients were enrolled. In an interim analysis of the first 62 patients to complete the study, mean baseline BCVA was 59.8 letters (~20/63 Snellen). Mean total lesion size on FA was 8.5 mm2 with 53.2% having some classic CNV component. At the 9 month endpoint, the mean change in BCVA in the OHR-102 combination group (n=29) was +10.4 letters vs +6.3 letters in the RBZ PRN monotherapy group (n=33). At least 3 line vision gain was seen in 48.3% in the combination group vs 21.2% in the monotherapy group. Subretinal hyper-reflective material (SHRM) was noted at baseline in 87% of these 62 patients. At month 9, there was a 75% reduction and 59% had total resolution of SHRM in the combination group vs 56% reduction and 44% had total resolution in the monotherapy group. Visual gains correlated with anatomic improvements in the OHR-102 combination group. There was no difference in frequency of RBZ retreatment between the groups. No safety issues were identified. Final Phase 2 data will be presented.
In the interim analysis, OHR-102 BID used with RBZ PRN demonstrated marked improvements over RBZ monotherapy in mean gain in visual acuity and percentage of patients gaining ≥ 3 lines, ≥4 lines, and ≥5 lines of vision. Final data will determine the ability of OHR-102 to provide improved vision when used in combination with anti-VEGF treatments.
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