Characterization of Anatomic and Visual Function Outcomes in Patients With Full-Thickness Macular Hole in Ocriplasmin Phase 3 Trials.

Abstract

PURPOSE:

To characterize anatomic and visual outcomes in patients with full-thickness macular hole (FTMH) at baseline in ocriplasmin phase 3 clinical trials, focusing on the relationship between resolution of vitreomacular adhesion and FTMH closure.

DESIGN:

Two multicenter, randomized, double-masked clinical trials.

METHODS:

Pharmacologic FTMH closure was one of multiple secondary endpoints. OCT scans were obtained at baseline and at all postinjection visits, and for patients with baseline FTMH, evaluated for FTMH width, vitreomacular adhesion, and epiretinal membrane.

RESULTS:

FTMH closure was observed in a greater proportion of ocriplasmin- vs vehicle-injected patients with baseline FTMH width ≤250 μm (58.3% vs 16.0%, P < .001) and >250 to ≤400 μm (36.8% vs 5.3%, P = .009). Among FTMH patients in the ocriplasmin group, ≥2-line visual acuity gains at month 6 were achieved by a greater percentage of those who achieved hole closure at day 28 vs those who did not achieve this outcome (72.1% vs 25.4%).

CONCLUSIONS:

Ocriplasmin demonstrated efficacy in closure of small and medium FTMH, and in FTMH without epiretinal membrane at baseline. Visual acuity gains occurred more frequently when hole closure was achieved after ocriplasmin treatment compared to when this outcome did not occur. Ocriplasmin treatment is an additional option for the management of patients with FTMH and vitreomacular adhesion.

• Authors: Pravin U Dugel, Carl Regillo, Dean Eliott
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 160 Issue 1 Pg. 94-9.e1 (Jul 2015) ISSN: 1879-1891 [Electronic] United States
• PMID: 25818925 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

• Fibrinolytic Agents
• Peptide Fragments
• microplasmin
• Fibrinolysin

Topics

• Adult
• Aged
• Double-Blind Method
• Female
• Fibrinolysin (therapeutic use)
• Fibrinolytic Agents (therapeutic use)
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Peptide Fragments (therapeutic use)
• Retina (pathology)
• Retinal Perforations (diagnosis, drug therapy, physiopathology)
• Tomography, Optical Coherence
• Visual Acuity (physiology)
• Vitreous Body (pathology)