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Deze abstract is toegekend aan sessie FAB: Fluorescein Angiography Club Belgium
TitelTreatment of Symptomatic Vitreomacular Adhesions (VMA) With Ocriplasmin: A Subgroup Analysis of the Phase III MIVI-TRUST Program
DoelTo evaluate the safety and efficacy of ocriplasmin for the treatment of patients with symptomatic VMA.
MethodesMIVI-006 and MIVI-007 were randomized, placebo-controlled, double-masked, multicenter trials, investigating a single intravitreal injection (125 µg [100 µL]) of ocriplasmin for the treatment of symptomatic VMA compared to 100 µL placebo. Primary end point was pharmacological resolution of VMA at day 28. Patients were followed for 6 months. We present here the visual acuity responder analysis from the subset of patients who had baseline vitreomacular traction (VMT) syndrome and Full Thickness macular hole(FTMH).
Resultaten188 and 106 of a total 464 ocriplasmin-treated eyes had VMT syndrome and FTMH at baseline, respectively. Of these, 29.8% of eyes with VMT syndrome had resolution of VMA and 40.6% of eyes with FTMH had macular hole closure at day 28. 41.1% and 14.3 % of patients in the VMT syndrome subset achieved ≥2 and ≥3 line improvements in visual acuity, respectively. 76.7% and 51.2% of patients in the FTMH subset achieved ≥2 and ≥3 line improvements in visual acuity, respectively. A majority of the adverse events in all patients occurred within the first 7 days and were either transient or temporary in nature.
ConclusieA single intravitreal dose of 125 µg ocriplasmin achieved clinically significant visual acuity results in VMT syndrome and FTMH patients who responded to treatment, defined here as resolution of VMA or FTMH closure. Treatment was well tolerated with a majority of adverse events being transient and occurring within the first 7 days of therapy. Ocriplasmin could provide a minimally invasive pharmacologic option to treat symptomatic VMA including FTMH.
Auteur 1
NaamSTALMANS
InitialenP
InstituutOogheelkunde UZLeuven
StadLeuven
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