Characterization of anatomic and visual function outcomes in patients with full-thickness macular hole in ocriplasmin phase 3 trials

Pravin U. Dugel, Carl Regillo, Dean Eliott

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

Purpose To characterize anatomic and visual outcomes in patients with full-thickness macular hole (FTMH) at baseline in ocriplasmin phase 3 clinical trials, focusing on the relationship between resolution of vitreomacular adhesion and FTMH closure. Design Two multicenter, randomized, double-masked clinical trials. Methods Pharmacologic FTMH closure was one of multiple secondary endpoints. OCT scans were obtained at baseline and at all postinjection visits, and for patients with baseline FTMH, evaluated for FTMH width, vitreomacular adhesion, and epiretinal membrane. Results FTMH closure was observed in a greater proportion of ocriplasmin- vs vehicle-injected patients with baseline FTMH width ≤250 μm (58.3% vs 16.0%, P <.001) and >250 to ≤400 μm (36.8% vs 5.3%, P =.009). Among FTMH patients in the ocriplasmin group, ≥2-line visual acuity gains at month 6 were achieved by a greater percentage of those who achieved hole closure at day 28 vs those who did not achieve this outcome (72.1% vs 25.4%). Conclusions Ocriplasmin demonstrated efficacy in closure of small and medium FTMH, and in FTMH without epiretinal membrane at baseline. Visual acuity gains occurred more frequently when hole closure was achieved after ocriplasmin treatment compared to when this outcome did not occur. Ocriplasmin treatment is an additional option for the management of patients with FTMH and vitreomacular adhesion.

Original languageEnglish
Pages (from-to)94-99.e1
JournalAmerican Journal of Ophthalmology
Volume160
Issue number1
DOIs
StatePublished - 1 Jul 2015
Externally publishedYes

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