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Brian C Joondeph, Jay S Duker, David S Boyer, Jeffrey S Heier, Peter K Kaiser, Mathew W MacCumber, Dante Joseph Pieramici; ORBIT: A phase IV clinical study - lessons learned from patient selection criteria for ocriplasmin intravitreal injection. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4063.
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The goal of the Phase IV ORBIT study is to prospectively and systematically collect real-world data on clinical efficacy and safety outcomes in symptomatic vitreomacular adhesion (VMA) patients treated with ocriplasmin according to standard of care in US retina clinics. Another objective of the study is to further define patient criteria that will improve clinical outcomes compared to those from the Phase III MIVI-TRUST trial results.
ORBIT is a multicenter, prospective, observational Phase IV study that has enrolled 542 patients across 90 clinical sites. Patients are enrolled at the time of a single injection of ocriplasmin 0.125 µg and 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. Images taken by spectral-domain optical coherence tomography are uploaded to a central reading center for independent review.
Here we present the complete patient baseline data and the efficacy results up to 6 months follow-up according to various patient characteristics. Pharmacological VMA resolution at 1 week, 1 month, and 6 months will be reported according to key baseline characteristics: adhesion size, lens status, injection position, presence of full-thickness macular hole, and presence of an epiretinal membrane. Final 6-month efficacy data, as well as safety reports, will be presented.
Data collected from the ORBIT study will provide a real-world efficacy and safety profile of ocriplasmin, better characterize postinjection patient experiences, and help identify patients who may respond best to ocriplasmin therapy. The results presented here will further characterize appropriate patient selection for ocriplasmin treatment compared to the patient characteristics identified from the Phase III MIVI-TRUST studies, including injection position which will be the first time this data is reported.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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