First Author: P.Lanzetta ITALY
Co Author(s): 0 0 0 0 0 0 0 0 0
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To report the effect of of intravitreal ocriplasmin injection on vision-related quality-of-life, as determined on the patient-reported Visual Function Questionnaire of the National Eye Institute (NEI-VFQ-25), in cases with vitreomacular traction (VMT) including when associated with macular hole (MH).
TG-MV-006 and TG-MV-007 were multicenter, randomized, double-masked, vehicle-controlled, phase 3 trials designed to test the efficacy and safety of a single intravitreal injection of ocriplasmin in patients with symptomatic VMA/ VMT, including when associated with macular hole. The assessment of vision-related functionality was a secondary endpoint in the efficacy analyses.
Eligible patients, 18 years and older were randomly assigned to receive a single intravitreal injection of either 125 μg of ocriplasmin or vehicle. The NEI-VFQ-25 (which includes 11 visual function subscales and a general health subscale) was administered at baseline and 6 months post-ocriplasmin. Changes in NEI VFQ-25 scores from baseline of ≥5 points were considered clinically meaningful. Changes in NEI-VFQ-25 scores between treatment groups were compared using an ANOVA model, with covariates being treatment, age, gender, race, BL VFQ-25 score and study. Data presented are a comparison between baseline and 6 months post-ocriplasmin.
Of a total of 652 patients, 464 and 188 patients, respectively, received ocriplasmin and vehicle. There was significant improvement in mean NEI-VFQ-25 composite score in the ocriplasmin arm (3.4) as compared to vehicle (0.7); P=0.005; as well as on several subscales – vision-related dependency (1.7 vs. -2.1; P=0.009), driving difficulty (2.7 vs. -1.5; P=0.027), distance vision (4.1 vs. 0.8; P=0.034) and general vision (6.1 vs. 2.1; P=0.003). The proportion of patients achieving a ≥5-point increase in NEI-VFQ-25 composite score was significantly greater in the ocriplasmin arm as compared with vehicle(36.0% vs. 27.2%; P=0.033), those with ≥5-point decrease was significantly lower in the ocriplasmin arm as compared with placebo (15.0% vs. 24.3%; P=0.005). Additional improvements in NEI VFQ-25 composite score, as well as various subscale scores, were observed in patients in whom VMA resolution was observed on optical coherence tomography on Day 28.
Ocriplasmin produces clinically meaningful improvement in vision-related disability in patients with symptomatic VMA/VMT including when associated with macular holes less than 400 microns. Subset analyses revealed that the patients who met the primary endpoint of non-surgical VMA resolution at day 28 also reported better vision-related functionality.