Subfoveal Lucency after Treatment of Vitreomacular Traction without Macular Hole in the Phase 3 Trials of Ocriplasmin Vitreolysis.
(Clinical Trial, Phase III;Journal Article;Multicenter Study)
PURPOSE: To describe the clinical impact of subfoveal lucency (SFL) seen on OCT before and after treatment of vitreomacular traction (VMT) or symptomatic vitreomacular adhesion (VMA) without macular hole (MH) in the prospective phase 3 trials of ocriplasmin vitreolysis. DESIGN: Randomized double-blind placebo-controlled multicenter study. PARTICIPANTS: Four hundred ninety-nine eyes with VMT or VMA without MH. METHODS: Eyes were randomized to either a single intravitreal injection of ocriplasmin or placebo treatment and were followed up for 6 months. MAIN OUTCOME MEASURES: Eyes were analyzed for presence, dimensions, and course of SFL on OCT, release of VMT, and their effect on visual acuity (VA). RESULTS: Among eyes without baseline SFL, new SFL was more frequent after ocriplasmin than placebo at week 1 (23.1% vs. 6.54%; P = 0.0002) and week 2 (19.7% vs. 3.85%; P = 0.0001), but was similar in frequency by week 4 (8.37% vs. 7.69%; P = 0.83). Six-month VA for eyes demonstrating SFL after ocriplasmin during the first 2 weeks was comparable with those without SFL at any point in the study (P = 0.12). In placebo-treated eyes but not ocriplasmin-treated eyes, SFL was associated with worse VA at all visits. The increase in SFL width from baseline to week 2 was significantly greater with ocriplasmin than placebo (P = 0.029). Among ocriplasmin-treated eyes at month 6, those with SFL and VMT release had better VA than those with SFL and persistent adhesion (P = 0.037) and similar VA to those with persistent adhesion without SFL (P = 0.17). In the placebo group, those with baseline SFL showed low rates of spontaneous VMT release at month 6 compared with those without baseline SFL (3/21 eyes vs. 33/99 eyes; P = 0.045). CONCLUSIONS: Compared with placebo, SFL occurred more frequently only in the initial weeks after treatment with ocriplasmin. When SFL developed after ocriplasmin administration, VA was not impacted at the 6-month visit. Persistent SFL in ocriplasmin-treated eyes at month 6 was associated with poorer vision if VMT had not released. Eyes with SFL at baseline had low rates of spontaneous VMT release and may need treatment.
Thomas, AS; Folgar, FA; Jaffe, GJ; Toth, CA; Mahmoud, TH
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