Abstract
Purpose :
To assess generalized- (GD) and focal-disruption (FD) of the ellipsoid zone (EZ) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following a single intravitreal injection of ocriplasmin (0.125 mg).
Methods :
OZONE was a Phase 4, retrospective study of patients with sVMA treated with intravitreal ocriplasmin. Data from patients 18 years or older with a diagnosis of sVMA with at least 6 months of follow-up after ocriplasmin were included. A baseline visit within 30 days prior to ocriplasmin was required. SD-OCT was performed at baseline, and before Day 21 post-injection. Early observation (EO) data were obtained from the last SD-OCT scan available prior to Day 21. Last observation (LO) data were obtained from the last SD-OCT scan performed up to a maximum of 6 months post-injection or prior to vitrectomy. The main outcome measure was the development of new and the evolution of existing or new FD/GD by EO and LO. Fisher exact tests were used to assess if baseline characteristics were associated with persistent FD/GD at LO.
Results :
The study enrolled 134 eyes of 134 patients from 22 retina centers across the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) were without EZ disruption. Among eyes without FD or GD at baseline, 13 (50%) developed FD and 8 (30.8%) developed GD following ocriplasmin. By LO, improvement or resolution of FD/GD was seen in over 80% of these eyes. Presence of FD/GD at baseline was associated with persistent FD/GD at LO (P<0.001) and less than 40% of these eyes had improving or resolving EZ integrity at LO. Presence of MH at baseline was associated with persistent FD (P=0.027), but not GD (P=0.281) at LO.
Conclusions :
The finding that a large majority of eyes had FD or GD prior to treatment with ocriplasmin indicates that EZ disruptions are common in sVMA and suggest that FD/GD are likely part of the natural history of this disorder. Presence of EZ disruptions at baseline were associated with persistent disruptions at LO. Given the high prevalence of FD/GD prior to treatment with ocriplasmin, it is likely that EZ disruptions arising after ocriplasmin treatment are at least in part due to the natural history of sVMA. Prospective analyses which include a sham control group would be required to test this hypothesis.
This is a 2021 ARVO Annual Meeting abstract.