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Dante J. Pieramici, David S. Boyer; The Phase III MIVI-TRUST Clinical Trial Data: Subgroup Responder Analysis of a Single Intravitreal Injection of Ocriplasmin in patients with Full Thickness Macular Hole. Invest. Ophthalmol. Vis. Sci. 2012;53(14):947.
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The purpose of the MIVI-TRUST Phase III program was to investigate the effect of a single intravitreal injection of ocriplasmin for the resolution of symptomatic vitreomacular adhesion (VMA). An important secondary endpoint included non-surgical closure of full thickness macular hole (FTMH). The pathogenesis of which has been related to the progression of tractional forces caused by unresolved vitreomacular adhesion.
153 of a total 652 treated eyes had FTMH at baseline. Of these, 106 eyes were randomized to receive a single intravitreal injection of ocriplasmin 125µg (100µl) and 47 eyes received placebo (100µl). Assessments included best corrected visual acuity (ETDRS letters), optical coherence tomography and review of adverse events.
VMA resolution was achieved in 50.0% of ocriplasmin-treated eyes, compared with 25.5% of placebo-treated eyes (p=0.006). At day 28, 40.6% of the ocriplasmin-treated eyes demonstrated nonsurgical FTMH closure as compared to 10.6% (p 250 µm, was 58.3% and 24.6%, respectively. Visual acuity improvements of ≥2 and ≥3 lines in ocriplasmin-treated patients with nonsurgical FTMH-closure were 76.7% and 51.2%, respectively, at month 6. A majority of adverse events occurred within the first 7 days of treatment. For example, the incidence of floaters was 12.9% in the first week and 3.9% between one week and study end at 6 months. No cases of endophthalmitis were observed.
A single intravitreal dose of 125 µg of ocriplasmin achieved FTMH closure in approximately 40% of patients. Pharmacologic resolution of this anatomic defect resulted in clinically significant visual acuity benefit in patients with FTMH. Treatment was well tolerated by patients. Ocriplasmin could provide a minimally invasive pharmacologic approach to treat patients with FTMH.
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