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Baruch D. Kuppermann; The Phase III MIVI-TRUST Clinical Trial Data: Subgroup Responder Analysis of a Single Intravitreal Injection of Ocriplasmin in patients with Vitreomacular Traction. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2754.
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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).
The MIVI-TRUST program, which consisted of two large phase III clinical trials, investigated a single intravitreal injection 125µg (100µl) of ocriplasmin compared to a single 100µl placebo injection for the pharmacological treatment of symptomatic VMA. Primary end point of the study was nonsurgical resolution of VMA at day 28. Patients were followed for 6 months. 266 of a total 652 treated eyes had VMT (without concurrent macular hole and/or epiretinal membrane) at baseline. Of these, 188 received a single 125µg (100µl) intravitreal injection of ocriplasmin and 78 eyes received 100 µl of intravitreal placebo injection. Assessments included best corrected visual acuity (ETDRS letters), optical coherence tomography and a review of adverse events.
At day 28, 29.8% of ocriplasmin-treated eyes with VMT at baseline had resolution of VMA, on OCT, as compared to 7.7% of placebo-treated eyes (p≤0.001). In the ocriplasmin- treated patients with resolution of VMA, visual acuity improvements of ≥2 and ≥3 lines were achieved in 41.1% and 14.3%, respectively, at month 6. Ocular adverse events were generally mild and included floaters and photopsia. The 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 resolution of VMA in approximately 30% of patients. Resolution of this anatomic pathology resulted in clinically significant visual acuity benefits in patients with VMT. Treatment was well tolerated by patients. Ocriplasmin could provide a minimally invasive pharmacologic approach to treat patients with VMT.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00798317, NCT00781859
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