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Joseph I Markoff, David G Birch, Robert Sergott, Petra Kozma-Wiebe; Evaluation of full-field electroretinogram changes after ocriplasmin injection in a substudy of symptomatic vitreomacular adhesion subjects from the OASIS trial. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4050.
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Ocriplasmin has been associated in case reports with abnormal full-field electroretinograms (ffERG) and multifocal ERGs in patients with symptomatic vitreomacular adhesion (VMA). However, no study has evaluated symptomatic VMA and ffERGs after ocriplasmin injection in a randomized, prospective study for up to 2 years. OASIS is a Phase IIIb trial designed to assess long-term outcomes in subjects with symptomatic VMA. A ffERG substudy was designed to evaluate the relationship of ERG changes with anatomic and visual outcomes for up to 24 months after a single injection of ocriplasmin 0.125 mg.
The ERG subset included postinjection ERG data from 61 subjects (40 from the ocriplasmin group and 21 from the sham group). ERGs were recorded from both eyes at each visit (every 3 months) for a 2-year follow-up period and evaluated by a masked ERG expert. Abnormal ERG changes were defined as those greater than 40% from baseline starting at Day 7 or Day 28 (acute change).
The incidence of abnormal ERG changes was higher in the ocriplasmin group (16/40, 40.0%) than in the sham group (1/21, 4.8%). Most (13/16, 81.3%) ERG changes resolved in the ocriplasmin group and 1/1 (100%) returned to normal in the sham group. Reversal of an ERG after ocriplasmin injection has not previously been reported in a large, randomized, prospective study. A review of ERG cases (those that severely diminished and then reversed) along with optical coherence tomography will be presented. Three patients who did not recover at 2 years will also be discussed. The rate of VMA resolution was higher among ocriplasmin-treated subjects with abnormal ERGs than in those with normal ERGs. Best-corrected visual acuity (BCVA) did not correlate with ERG changes. In the ocriplasmin group, 15/16 patients with ERG changes had improved BCVA by the end of the study. A mechanism will be proposed to account for these findings.
The majority of ERG changes in subjects treated with ocriplasmin were normal, and the majority of those that were abnormal reversed to normal. The likelihood of VMA resolution was greater in subjects with acute ERG changes than in those without. There was no correlation found between BCVA and ERG changes.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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