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


Journal

Retina (Philadelphia, Pa.)
ISSN: 1539-2864
Titre abrégé: Retina
Pays: United States
ID NLM: 8309919

Informations de publication

Date de publication:
Jul 2020
Historique:
pubmed: 2 7 2019
medline: 1 7 2021
entrez: 2 7 2019
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 31259807
doi: 10.1097/IAE.0000000000002599
pmc: PMC7302331
pii: 00006982-202007000-00015
doi:

Substances chimiques

Peptide Fragments 0
microplasmin 7V6HE3DM5A
Fibrinolysin EC 3.4.21.7

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1331-1338

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Auteurs

Calvin Mein (C)

Retinal Consultants of San Antonio, San Antonio, Texas.

Pravin U Dugel (PU)

Retinal Consultants of Arizona, Phoenix, Arizona.
USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.

Leonard Feiner (L)

Hackensack University Medical Center, Hackensack, New Jersey.
NJ Retina, Ridgewood, New Jersey.

Kim Drenser (K)

Associated Retinal Consultants P.C., Royal Oak, Michigan.

Daniel Miller (D)

Cincinnati Eye Institute, Cincinnati, Ohio.

Matthew Benz (M)

Retinal Consultants Houston, Houston, Texas.

Esmeralda Meunier (E)

Oxurion (formerly ThromboGenics), Leuven, Belgium.

Lionel Moro (L)

Oxurion (formerly ThromboGenics), Leuven, Belgium.

Mitchell S Fineman (MS)

Mid Atlantic Retina, Philadelphia, Pennsylvania; and.
Wills Eye Hospital, Philadelphia, Pennsylvania.

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Classifications MeSH