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PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY.

Authors
  • Mein, Calvin1
  • Dugel, Pravin U2, 3
  • Feiner, Leonard4, 5
  • Drenser, Kim6
  • Miller, Daniel7
  • Benz, Matthew8
  • Meunier, Esmeralda9
  • Moro, Lionel9
  • Fineman, Mitchell S10, 11
  • 1 Retinal Consultants of San Antonio, San Antonio, Texas.
  • 2 Retinal Consultants of Arizona, Phoenix, Arizona.
  • 3 USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
  • 4 Hackensack University Medical Center, Hackensack, New Jersey. , (Jersey)
  • 5 NJ Retina, Ridgewood, New Jersey. , (Jersey)
  • 6 Associated Retinal Consultants P.C., Royal Oak, Michigan.
  • 7 Cincinnati Eye Institute, Cincinnati, Ohio.
  • 8 Retinal Consultants Houston, Houston, Texas.
  • 9 Oxurion (formerly ThromboGenics), Leuven, Belgium. , (Belgium)
  • 10 Mid Atlantic Retina, Philadelphia, Pennsylvania.
  • 11 Wills Eye Hospital, Philadelphia, Pennsylvania.
Type
Published Article
Journal
Retina (Philadelphia, Pa.)
Publication Date
Jul 01, 2020
Volume
40
Issue
7
Pages
1331–1338
Identifiers
DOI: 10.1097/IAE.0000000000002599
PMID: 31259807
Source
Medline
Language
English
License
Unknown

Abstract

To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole. This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed. Of the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. A larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.

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