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Michael Tolentino, OASIS Study Group; Long-term Clinical Outcomes with Ocriplasmin: The OASIS Study - Baseline Demographics and Ocular Characteristics. Invest. Ophthalmol. Vis. Sci. 2014;55(13):305.
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To present the demographics and baseline ocular characteristics of subjects enrolled in the OASIS study.
The OASIS study is an ongoing study evaluating the long-term efficacy and safety of a single intravitreal injection of ocriplasmin 0.125mg compared to sham treatment in subjects with symptomatic vitreomacular adhesion/vitreomacular traction (VMT) including macular hole with no epiretinal membranes (ERM) at baseline. This Phase 3b, 24-months study is randomized, double-masked and multicenter with optional cross-over treatment. Selected sites participated in full-field ERG (ffERG) and microperimetry (MP1) sub-studies.
Overall two hundred and twenty subjects were enrolled at 25 retina centers in the United States between November 2011 and November 2012: 131 subjects in the main study, 62 in the ffERG sub-study and 27 in the MP-1 sub-study. The mean age of subjects was 69.1 years (SD: 10.29). The majority of the subjects were female (67.3%), White (89.5%) and non-Hispanic (92.7%). Masked data at Baseline showed, the mean BCVA was 63.2 (SD: 9.65) ETDRS letters(20/63 Snellen). Metamorphopsia was present in 171 subjects (77.7%) (95% CI: 72.2; 83.2) on Amsler grid. Macular hole was diagnosed in 76 subjects (34.5%). All 220 subjects had VMA and partial PVD on SD-OCT.
The present report describes the baseline demographics and ocular characteristics of subjects enrolled in the OASIS study, which is designed to provide long-term efficacy and safety data in subjects with symptomatic vitreomacular adhesion/VMT including macular hole and excluding ERM.
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