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Jay S Duker, David S Boyer, Jeffrey S Heier, Peter K Kaiser, Mathew W MacCumber, Dante Joseph Pieramici; Six-Month Results From the ORBIT Study: Ocriplasmin Research to Better Inform Treatment of Symptomatic Vitreomacular Adhesion. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1203. doi: https://doi.org/.
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The large Phase IV ORBIT study prospectively and systematically collects real-world data on clinical outcomes and safety in patients receiving ocriplasmin according to standard of care in US retina clinics. This study provides real-world efficacy and safety data complementary to the Phase III MIVI-TRUST trials and may further define appropriate patients for ocriplasmin treatment.
ORBIT is a multicenter, prospective, observational Phase IV study that plans to enroll 1500 patients from approximately 120 US clinical retina sites. Patients are enrolled at the time of ocriplasmin injection, and baseline and post-injection data are collected; patients are followed for up to 12 months. Treatment decisions, including the frequency and timing of patient visits after injection, are at the discretion of the treating physician following standard of care, and are not mandated by the study design. Clinical effectiveness and safety data are entered in electronic case report forms, based on investigator assessments. SD-OCT images are uploaded to a central reading center for independent review.
Here we present preliminary demographic and patient baseline data obtained from the initial 6 months of the ORBIT study. Data from both investigator and reading center assessments, as well as clinical outcome and safety data captured over the first 6 months of the study are included. As of 11/11/14, 243 patients were enrolled from 110 clinics. Baseline demographics and ocular characteristics for these 243 patients are presented in Table 1. Mean age is 79 years (range=46-92 years); 66% of patients are female. Pre-injection ocular symptoms (in >3% of patients) included decreased visual acuity, metamorphopsia, floaters, central visual field defect/central black spot, difficulty reading at close distance, photopsia, and eye pain/ocular discomfort. (Table 1)
Data collected from the ORBIT study will assess the real-world efficacy and safety profile of ocriplasmin, better characterize post-injection patient experiences, and help identify patients who may respond best to ocriplasmin therapy.
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