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TitleRecovery of visual acuity following a single ocriplasmin injection for symptomatic vitreomacular adhesion - Results of Phase 3 Trials
PurposeTo examine the impact on visual acuity (VA) and function for 6 months after a single intravitreal ocriplasmin injection in patients with vitreomacular traction (VMT) or macular hole.
MethodsVA testing (ETDRS) and visual function assessment (VFQ-25) at baseline and 6 months after treatment were done on patients from 2 phase 3 trials receiving intravitreal ocriplasmin 125µg, n=464 vs placebo, n=188.
ResultsAt 6 months, best corrected visual acuity improved ≥2 lines in 28% of all ocriplasmin-treated eyes vs 17.1% of all placebo eyes (p=0.003) and ≥3 lines in 12.3% vs 6.4% (p=0.024). Among patients with baseline ≤20/50, 25.1% ocriplasmin-treated eyes gained ≥3 lines vs 11.4% of placebo (p<0.001). In macular hole patients, 76.7% (n=33) of ocriplasmin-treated eyes with hole closure at month 6 gained ≥2 lines, and 51.2% (n=22) gained ≥3 lines. In VMT patients, 41.1% (n=23) of ocriplasmin-treated eyes gained ≥2 lines following resolution, and 14.3% (n=8) gained ≥3 lines. Ocriplasmin patients also improved on VFQ-25 composite scale by 3.4 vs 0.7 for placebo (p=0.004) and 6/11 subscales. Median time to onset for a majority of adverse drug reactions (ADRs) occurred within the first 7 days of treatment, with ADRs Day 8 to end of study mirroring the placebo group.
ConclusionPatients receiving ocriplasmin reported significant improvements in VA and visual function over placebo. Ocriplasmin may provide a minimally invasive pharmacologic approach to treat patients with symptomatic vitreomacular adhesion and restore VA.
Authors 1
Last nameSTALMANS
InitialsP
DepartmentDept. Ophthalmology UZLeuven
CityLeuven
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