Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.

PURPOSE

To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole.

DESIGN

Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies.

PARTICIPANTS

A total of 652 randomized patients (464 receiving ocriplasmin; 188 receiving placebo).

METHODS

A single intravitreal injection of ocriplasmin 125 μg or placebo in the study eye.

MAIN OUTCOME MEASURES

Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28, nonsurgical full-thickness macular hole (FTMH) closure at month 6, and categoric improvement in best-corrected visual acuity (BCVA) at month 6.

RESULTS

Resolution of VMA at day 28 was achieved more often in younger patients (<65 years), eyes without epiretinal membrane, eyes with FTMH, phakic eyes, and eyes with a focal VMA ≤ 1500 μm. Eyes with FTMH width ≤ 250 μm were more likely to achieve nonsurgical FTMH closure. Categoric ≥ 2-line and ≥ 3-line improvement in BCVA occurred more often in younger patients (<65 years) and in patients with a lower baseline BCVA (<65 letters). Treatment differences in favor of ocriplasmin were generally observed across each subgroup of subpopulations studied.

CONCLUSIONS

Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations.