EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT: Results of the OASIS Trial ERG Substudy.

Abstract

PURPOSE:

To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin.

METHODS:

The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28.

RESULTS:

In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions.

CONCLUSION:

Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end.

• Authors: David G Birch, Matthew S Benz, Daniel M Miller, Andrew N Antoszyk, Joseph Markoff, Petra Kozma, Esmeralda Meunier, Robert C Sergott, OASIS Study Team
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 38 Issue 2 Pg. 364-378 (Feb 2018) ISSN: 1539-2864 [Electronic] United States
• PMID: 28198785 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Peptide Fragments
• microplasmin
• Fibrinolysin

Topics

• Adult
• Aged
• Aged, 80 and over
• Dose-Response Relationship, Drug
• Double-Blind Method
• Electroretinography (drug effects)
• Female
• Fibrinolysin (administration & dosage)
• Follow-Up Studies
• Humans
• Macula Lutea (pathology, physiopathology)
• Male
• Middle Aged
• Peptide Fragments (administration & dosage)
• Prospective Studies
• Retinal Perforations (complications, drug therapy, physiopathology)
• Time Factors
• Tissue Adhesions (drug therapy, etiology, physiopathology)
• Treatment Outcome
• Visual Acuity
• Vitreous Body (pathology, physiopathology)
• Vitreous Detachment (complications, drug therapy, physiopathology)