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.

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.

• Authors: Arnd Gandorfer, Matthew S Benz, Julia A Haller, Peter Stalmans, Stephen J Pakola, Aniz Girach, Anselm Kampik, Cynthia A Toth, Glenn J Jaffe, MIVI-TRUST Study Group
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 35 Issue 6 Pg. 1151-7 (Jun 2015) ISSN: 1539-2864 [Electronic] United States
• PMID: 25741816 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Peptide Fragments
• microplasmin
• Fibrinolysin

Topics

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