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Ramin Tadayoni, Danyel Carr, Zhenming Zhao, Aaron Osborne; Assessment of Anatomical and Functional Outcomes in the Ocriplasmin for Vitreomacular Traction Intravitreal Injection Decisions (OVIID 1) Trial. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1222. doi: https://doi.org/.
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Analysis of pooled data from 2 studies assessing the safety and clinical efficacy of ocriplasmin (clinicaltrials.gov ID NCT00781859 and NCT00798317, respectively) showed that the effect of ocriplasmin in inducing resolution of vitreomacular adhesion (VMA) is greatest in patients without epiretinal membrane (ERM) and in patients with a VMA diameter of <1500 μm. The OVIID 1 study (NCT02035748) has been designed to observe the anatomical and functional outcomes in VMT/sVMA patients treated with ocriplasmin.
Phase IV, multi-center, prospective, single-arm study in which patients diagnosed with VMT/sVMA are treated with ocriplasmin 125 μg by intravitreal injection.<br /> <br /> The study population includes adult subjects diagnosed with VMT/sVMA, with evidence of focal VMT visible on spectral domain-optical coherence tomography (SD-OCT). Key exclusion criteria include presence of ERM over the macula at baseline, broad VMT/VMA (>1500 μm) at baseline, or macular hole (MH) >400 µm in diameter in study eye. The study includes a total of 6 planned visits (including screening visit): During visit 1, subjects receive a single intravitreal injection of ocriplasmin, as per the country’s product label. Subsequent visits occur on Days 7, 28, 90, and 180. Safety is assessed through the use of reported adverse events and ophthalmologic examinations.
The study is planned to enroll 400 patients from about 90 centers in 11 countries across Europe and Canada. The primary efficacy endpoint is the proportion of patients with nonsurgical resolution of focal VMT/sVMA at Day 28, as determined by central reading center evaluation of SD-OCT data. Secondary and exploratory endpoints include changes in best-corrected visual acuity, proportion of subjects with closure of macular hole, changes in metamorphopsia, and visual function assessment (Table 1). Side effects are also monitored based on clinical information and high resolution SD-OCT of the macula and optic nerve head.
The systematic and standardized collection and evaluation of data on the use of ocriplasmin in different countries will contribute to the characterization of appropriate patients for ocriplasmin treatment, and provide additional insights into its safety profile.
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