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Posters

Improved vision-related functionality in patients with symptomatic vitreomacular adhesion, after intravitreal ocriplasmin injection - analyses from TG-MV-006 and TG-MV-007

Poster Details

First Author: P.Lanzetta ITALY

Co Author(s):                      0   0 0   0 0   0 0   0 0

Abstract Details



Purpose:

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).

Setting:

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.

Methods:

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.

Results:

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.

Conclusions:

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.

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