Pravin U Dugel1, Carl Regillo2, Dean Eliott3. 1. Retinal Consultants of Arizona, Phoenix, Arizona; Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: pdugel@gmail.com. 2. Wills Eye Hospital, Philadelphia, Pennsylvania; Thomas Jefferson University, Philadelphia, Pennsylvania. 3. Massachusetts Eye and Ear Infirmary, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
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.
RCT Entities:
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.
Authors: D H W Steel; C Parkes; V T Papastavrou; P J Avery; I A El-Ghrably; M S Habib; M T Sandinha; J Smith; K P Stannard; D Vaideanu-Collins; R J Hillier Journal: Eye (Lond) Date: 2016-03-11 Impact factor: 3.775