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Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion : Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment ( MIVI-TRUST ) Trials . IMPORTANCE The impact of vitreomacular adhesion ( VMA ) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction ( VMT ) has not yet been documented , to our knowledge . OBJECTIVE To determine the impact of intravitreal ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) during a 6-month follow-up in patients with symptomatic VMA . DESIGN , SETTING , AND PARTICIPANTS Two multicenter , randomized , masked , phase 3 clinical trials ( studies TG-MV-006 [ between December 2008 and April 2010 ] and TG-MV-007 [ between December 2008 and July 2010 ] ) at clinic-based centers in the United States and Europe . A total of 652 patients with symptomatic VMA/VMT , including when associated with a macular hole 400 μm or smaller , were studied . Analysis was by intent-to-treat population and performed in May 2013 . INTERVENTIONS Patients with symptomatic VMA/VMT were randomly assigned ( 2:1 or 3:1 in study TG-MV-006 and study TG-MV-007 , respectively ) to receive a single intravitreal injection of ocriplasmin , 125 μg , or placebo-injected vehicle ( placebo ) . The NEI VFQ-25 was administered at baseline and 6 months following ocriplasmin injection . MAIN OUTCOMES AND MEASURES Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change ( ≥5 points ) in scores . RESULTS Across the 2 studies , 464 patients received ocriplasmin and 188 received placebo . At 6 months , the ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group ( mean change , 3.4 vs 0.7 , respectively ; P = .005 ) . Improvements were also noted in subscale scores , with the following respective mean changes for the ocriplasmin vs placebo groups : vision-related dependency , 1.7 vs -2.1 ( P = .009 ) ; driving difficulty , 2.7 vs -1.5 ( P = .03 ) ; distance vision activities , 4.1 vs 0.8 ( P = .03 ) ; and general vision , 6.1 vs 2.1 ( P = .003 ) . A higher proportion of the ocriplasmin group had a clinically meaningful ( ≥5-point ) improvement in NEI VFQ-25 composite score from baseline than the placebo group ( 36.0 % vs 27.2 % , respectively ; P = .03 ) . Fewer ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group ( 15.0 % vs 24.3 % , respectively ; P = .005 ) . Changes in NEI VFQ-25 composite score and various subscale scores were observed in ocriplasmin-treated patients who achieved VMA resolution at day 28 . CONCLUSIONS AND RELEVANCE Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT . TRIAL REGISTRATION clinicaltrials.gov Identifiers : NCT00781859 and NCT00798317 .
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Intervention_Pharmacological
Ocriplasmin
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Intervention_Surgical
vitreomacular adhesion ( VMA )
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Intervention_Physical
intravitreal ocriplasmin
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Intervention_Educational
( NEI VFQ-25 )
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Outcome_Physical
visual function
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Outcome_Other
changes between baseline and 6-month follow-up
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Outcome_Physical
NEI VFQ-25
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Outcome_Other
composite and subscale scores
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Outcome_Other
proportion of patients with a clinically meaningful change ( ≥5 points ) in scores
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Outcome_Other
greater mean improvements from baseline
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Outcome_Physical
the
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Outcome_Other
NEI VFQ-25 composite score
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Outcome_Other
subscale
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Outcome_Physical
NEI
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Outcome_Other
meaningful worsening
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Outcome_Physical
Changes in NEI VFQ-25 composite
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Participant_Condition
Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion
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Participant_Condition
patient-reported visual function in symptomatic VMA/vitreomacular traction ( VMT )
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Participant_Condition
patients with symptomatic VMA
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Participant_Sample-size
652 patients
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Participant_Condition
symptomatic VMA/VMT
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Participant_Sample-size
464 patients
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Participant_Sample-size
188 received