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Ramin Tadayoni, Danyel Crout Carr, Zhenming Zhao; The ocriplasmin for vitreomacular traction intravitreal injection decisions (OVIID-I) trial: full study results. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4045.
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OVIID-I is a Phase IV, multicenter, prospective, single-arm, open-label, interventional study designed to observe the anatomical and functional outcomes of a single injection of ocriplasmin over a 6-month follow-up period in patients with vitreomacular traction (VMT)/symptomatic vitreomacular adhesion (VMA) with focal VMT (≤1500 μm), absence of epiretinal membrane, and macular hole (MH) of ≤400 μm.
Key optical coherence tomography (OCT) inclusion/exclusion criteria were assessed by central reading center (CRC). Patients were followed for up to 6 study visits at the clinical site. A screening/baseline visit was followed by Visit 1, at which subjects received a single intravitreal injection of ocriplasmin 0.125 mg in a 0.1 mL volume as per the country’s product label. Subsequent to Visit 1, patients attended 4 postinjection visits at Day 7, Day 28, Day 90, and Day 180. The primary efficacy endpoint was nonsurgical VMT resolution at Day 28, as determined by CRC spectral-domain OCT. A key secondary endpoint was the proportion of patients with MH closure at Days 28, 90, and 180.
A total of 628 patients from 11 countries were enrolled. Among 468 patients treated, 466 were included in the full analysis set. The mean age was 72 years, 344 were female (73.8%), and 442 were Caucasian (94.8%). At baseline, 35 patients (7.5%) had VMT with small MH (≤250 μm), and 51 patients (10.9%) had VMT with medium MH (250-400 μm). The overall proportion of patients with nonsurgical VMT resolution at Day 28 was 47.4%. For patients with VMT without MH at baseline, the proportion with VMT resolution at Day 28 was 43.4%. The overall proportion of nonsurgical closure of MH at Day 28 was 39.5%. Nonsurgical closure of MH was greater (57.1%) in patients with small MH (≤250 µm) at baseline. No new safety signals or trends were observed that would alter the known safety profile of ocriplasmin.
OVIID-I is a CRC-supported study conducted to observe the anatomical and functional outcomes in VMT/symptomatic VMA patients treated with ocriplasmin over a 6-month period. Results from this study suggest appropriate patient selection confirmed by CRC may increase the likelihood of success after treatment with ocriplasmin.
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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