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

Retina. 2015 Jun;35(6):1151-7. doi: 10.1097/IAE.0000000000000508.

Abstract

Purpose: To 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.

Methods: Six 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.

Results: Overall, 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.

Conclusion: In 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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Eye Diseases / diagnosis
  • Eye Diseases / drug therapy*
  • Eye Diseases / physiopathology
  • Fibrinolysin / adverse effects
  • Fibrinolysin / therapeutic use*
  • Fibrinolytic Agents / adverse effects
  • Fibrinolytic Agents / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Peptide Fragments / adverse effects
  • Peptide Fragments / therapeutic use*
  • Retinal Diseases / diagnosis
  • Retinal Diseases / drug therapy*
  • Retinal Diseases / physiopathology
  • Retinal Perforations / diagnosis
  • Retinal Perforations / drug therapy*
  • Retinal Perforations / physiopathology
  • Sickness Impact Profile
  • Surveys and Questionnaires
  • Tissue Adhesions / drug therapy
  • Visual Acuity / physiology*
  • Vitreous Body / drug effects*
  • Vitreous Body / pathology

Substances

  • Fibrinolytic Agents
  • Peptide Fragments
  • microplasmin
  • Fibrinolysin