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Randomized Controlled Trial Multicenter Study
Association between anatomical resolution and functional outcomes in the mivi-trust studies using ocriplasmin to treat symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with macular hole.
- Arnd Gandorfer, Matthew S Benz, Julia A Haller, Peter Stalmans, Stephen J Pakola, Aniz Girach, Anselm Kampik, Cynthia A Toth, Glenn J Jaffe, and MIVI-TRUST Study Group.
- *Department of Ophthalmology, Klinikum der LMU, Munich, Germany; †MVZ, Memmingen, Germany; ‡Retina Consultants of Houston, Houston, Texas; §Wills Eye Hospital, Philadelphia, Pennsylvania; ¶Department of Ophthalmology, UZ Leuven, Leuven, Belgium; **Amakem NV, Diepenbeek, Belgium (formerly of ThromboGenics NV); ††NightstaRx Ltd, London, United Kingdom (formerly of ThromboGenics NV); ‡‡Department of Ophthalmology, Klinikum der LMU, Munich, Germany; and §§Duke Reading Center, Duke University School of Medicine, Durham, North Carolina.
- Retina (Philadelphia, Pa.). 2015 Jun 1; 35 (6): 1151-7.
PurposeTo evaluate visual function in patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction including when associated with macular hole after ocriplasmin treatment, and the association between resolution of the underlying condition and improvement in visual function.MethodsSix hundred and fifty-two patients from 2 Phase 3 trials received a single intravitreal injection of ocriplasmin 125 μg (n = 464) or placebo (n = 188). Mean and categorical changes from baseline in best-corrected visual acuity and 25-item Visual Function Questionnaire scores were used to evaluate visual function. Subgroups with VMA resolution and full-thickness macular hole closure were compared.ResultsOverall, 42% of patients who achieved VMA resolution at Day 28 had a ≥2-line improvement in best-corrected visual acuity at Month 6, and 20% had a ≥3-line improvement. Likewise, 69% of patients with nonsurgical full-thickness macular hole closure at Day 28 had a ≥2-line improvement at Month 6, and 48% had a ≥3-line best-corrected visual acuity improvement. Mean improvements in 25-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure.ConclusionIn patients with symptomatic VMA/vitreomacular traction, VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function. Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function.
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