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Peter Stalmans, Franklin Masin, Claudio Spera, Severine Durier, Lawrence Rasouliyan; Interim Results From INJECT: INvestigation of JETREA in Patients With Confirmed Vitreomacular Traction. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1237.
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The safety and clinical efficacy of JETREA (ocriplasmin) have been established in two phase 3 vehicle-controlled clinical studies. However, the long-term effects of ocriplasmin in a real-world setting have not been widely documented in large populations across different countries. The purpose of this study is to characterize baseline characteristics, safety profile, and clinical effectiveness of ocriplasmin in real-world settings across different countries.
Non-interventional, multicenter, prospective study in vitreomacular traction (VMT) patients treated with ocriplasmin. Enrolled patients are followed for 12 months. Frequency and timing of post-injection visits are at the discretion of the treating physician. Patient baseline characteristics collected include age, race, gender, presence and size of macular hole (MH), presence of ERM, and size of vitreomacular adhesion. Safety assessments include ocular symptoms and adverse events.
The interim analysis included 105 patients with available baseline OCT data and at least 28 days of follow-up. The majority of patients were female (62%), white (97%), with a mean age of 72 years (range 46 - 89 years). Most patients presented with VMT without macular hole: 64/105 (61%) with VMT only, and 41/105 (39%) with VMT plus MH. The most frequently reported adverse events were: drug ineffective (n=8), vitreous floaters (n=7), photopsia (n=7), and visual acuity reduced (n=5).
Results from this study provide insights into presenting characteristics of patients with VMT and VMT with MH, who receive ocriplasmin in a real world setting, and will contribute to the further characterization of ocriplasmin efficacy, safety profile, and global treatment patterns.
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