Dataset Information

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies.

ABSTRACT:

Purpose

To assess the effect of patient baseline characteristics on the efficacy of ocriplasmin treatment for symptomatic vitreomacular adhesion (VMA) with full-thickness macular hole (FTMH) from phase 3/4 studies.

Methods

Patients with symptomatic VMA and FTMH at baseline and receiving ocriplasmin treatment 125 ? g were pooled from the MIVI-TRUST, OASIS, and ORBIT studies. Multivariable logistic regression analysis was used to evaluate whether patient baseline characteristics were predictors of having VMA resolution by Day 28 and FTMH closure by Month 6.

Results

Two hundred and seventy-four patients receiving ocriplasmin treatment were assessed. Overall, 22.6% (62/274) of the patients experienced both VMA resolution by Day 28 and non-surgical FTMH closure by Month 6. Patients with FTMH ? 250 µm at baseline had a significantly higher success rate compared to those with FTMH > 400 µm (29.9% [41/137] vs 2.2% [1/48]; P = 0.009). In patients with VMA resolution by Day 28, both small FTMH size (P = 0.001) and FTMH width at RPE (P = 0.012) were significantly associated with a higher FTMH closure rate. Patients with VMA resolution had higher rates of FTMH closure. Previously identified baseline predictive factors, including age, lens status, or presence of epiretinal membrane (ERM) were not found to be predictive of both VMA release and FTMH closure.

Conclusion

The analysis revealed that FMTH ? 250 µm was the only factor predictive for achieving both pharmacological VMA resolution by Day 28 and nonsurgical FTMH closure by Month 6; neither lens status or presence of ERM, previously identified baseline characteristics favoring VMA resolution, showed statistically significant predictive power for both outcomes.

SUBMITTER: Joondeph BC

PROVIDER: S-EPMC7841271 | biostudies-literature | 2021 Jan-Mar

REPOSITORIES: biostudies-literature

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Publications

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies.

Joondeph Brian C BC Willems Paul P Raber Thomas T Duchateau Luc L Markoff Joseph J

Journal of ophthalmic & vision research 20210120 1

<h4>Purpose</h4>To assess the effect of patient baseline characteristics on the efficacy of ocriplasmin treatment for symptomatic vitreomacular adhesion (VMA) with full-thickness macular hole (FTMH) from phase 3/4 studies.<h4>Methods</h4>Patients with symptomatic VMA and FTMH at baseline and receiving ocriplasmin treatment 125 μ g were pooled from the MIVI-TRUST, OASIS, and ORBIT studies. Multivariable logistic regression analysis was used to evaluate whether patient baseline characteristics wer ...[more]

PMID: 33520127

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Project description:BackgroundIf left untreated, vitreomacular traction (VMT) will infrequently improve through spontaneous resolution of vitreomacular adhesion (VMA), and patients remain at risk of further deterioration in vision. The mainstay of treatment for VMT is vitrectomy, an invasive procedure that carries the risk of rare but serious complications and further vision loss. As such, a 'watch and wait' approach is often adopted before this surgical intervention is performed. Ocriplasmin (microplasmin) is a potential alternative treatment for patients with symptomatic VMT that may remove the requirement for vitrectomy.ObjectiveThe purpose of this study was to evaluate the cost-effectiveness of ocriplasmin for the treatment of VMT in comparison to standard of care.Study designA cohort-based computer simulation model was developed, capturing three mutually exclusive subgroups: 1) VMT without epiretinal membrane (ERM) or full thickness macular hole (FTMH), 2) VMT with ERM but no FTMH, and 3) VMT with FTMH. Transition probabilities between health states, utilities, and resource utilisation were estimated based on clinical trial results, the literature, and expert opinion. The cost per quality-adjusted life year (QALY) gained was estimated over a lifetime, using UK unit costs and utilities associated with visual acuity, adverse events, metamorphopsia, and surgical interventions.SettingAnalyses were conducted from a UK payer perspective.PopulationTransition probabilities for the model were primarily estimated from patient-level data from the combined Phase 3 MIVI-TRUST trials in patients with symptomatic VMA/VMT, including when associated with a FTMH ≤400 µm.InterventionOcriplasmin (microplasmin) is a one-time intravitreal injection designed specifically to release the abnormal traction between the macula and the vitreous and thereby treat VMT, as well as macular hole with persistent vitreous attachment.Main outcome measureThe main outcome measure of the economic evaluation was cost per QALY.ResultsIn all subgroups, ocriplasmin management generated more QALYs: 1) VMT without ERM or FTMH (0.105, (0.036, 0.191)); 2) VMT with ERM but no FTMH (0.041, (0.011, 0.131)); and 3) VMT with FTMH (0.053, (-0.002, 0.113)). The initial treatment costs were partially offset by later savings and net costs were estimated at £1,901 (£1,325, £2,474), £2,491 (£1,067, £2,511), and £1,912 (£1,233, £2,506), respectively. Costs per QALY were estimated at £18,056 (£8,241, £64,874), £61,059 (£8,269, £168,664), and £36,250 (-£144,788, £290,338), respectively. Short-term efficacy parameters were found to be key drivers of results.ConclusionOcriplasmin is most cost-effective in VMT patients without either ERM or FTMH.

Dataset Information

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies.

Purpose

Methods

Results

Conclusion

Publications

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies.

Similar Datasets

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