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Baseline characteristics predictive of vitreomacular adhesion resolution and full-thickness macular hole identified during subgroup analyses of the ocriplasmin clinical trial program

Poster Details

First Author: T.Jackson UK

Co Author(s):                  

Abstract Details



Purpose:

Intravitreal ocriplasmin is indicated for the treatment of vitreomacular traction, including when associated with full-thickness macular holes (FTMH) ≤400 μm. Two phase III, randomised, double masked clinical trials of ocriplasmin met their primary endpoint, with higher rates of vitreomacular adhesion (VMA) release at day 28 (10.1% vs 26.5%, p<0.001), compared to an intravitreal placebo injection. We aimed to identify the factors that predict a response to ocriplasmin, to refine case selection and increase the anatomic success rates.

Setting:

The two multicenter phase III clinical trials were performed at 89 sites in both Europe and the USA.

Methods:

Post hoc multivariate regression analysis of the phase III trial data (NCT00781859, TG-MV-006 and NCT00798317, TG-MV-007) was performed to identify baseline features predictive of vitreomacular adhesion (VMA) resolution at Day 28 and FTMH closure at Month 6. Nonocular predictors included treatment group, study (TG-MV-006 or TG-MV-007), age, gender, race, region, and body mass index. Ocular predictors included expected need for vitrectomy, FTMH presence, epiretinal membrane (ERM) absence, VMA diameter, phakic lens status, diabetic retinopathy, and best-corrected visual acuity. We undertook a prospectively defined analysis of pooled data with adjustment for covariates through logistic regression. Univariate analysis was done initially, then covariates were eliminated if not significant at the 0.05 level. The remaining covariates were analyzed using a multivariate logistic regression model.

Results:

Of 652 patients enrolled in the 2 trials, 464 received ocriplasmin and 188 received placebo. Baseline predictors of VMA resolution at Day 28 were: age <65 years, presence of FTMH, absence of ERM, VMA diameter ≤1500 µm, and phakic lens status. Within each subgroup, a significantly greater proportion of participant receiving ocriplasmin achieved VMA resolution at Day 28 compared with those receiving placebo. FTMH was present in 106 and 47 participants in the ocriplasmin and placebo groups, respectively, at baseline. Factors predictive of FTMH closure at Day 28 were FTMH diameter and ocriplasmin treatment. Participants with a FTMH ≤250 µm were significantly more likely to achieve hole closure with ocriplasmin than with placebo: ≤250 µm: 58.3% versus 16.0% (p<0.001); >250 µm: 24.6% versus 4.5% (p=0.031).

Conclusions:

Patients with VMA adhesion ≤1500 µm and no ERM are the most likely to respond to ocriplasmin, and those with small FTMHs are most likely to close. These results may help refine case selection, increase the success rate with ocriplasmin, and inform future studies. FINANCIAL INTEREST: NONE

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