Real world outcomes of ocriplasmin use by members of the British and Eire Association of Vitreoretinal Surgeons

Abstract

Purpose To describe a survey of the use of ocriplasmin by members of the British and Eire Association of VitreoRetinal Surgeons (BEAVRS) for VitreoMacular Traction (VMT) and Full Thickness Macular Hole (FTMH) and compare it to published MIVI TRUST trial data. Methods All 173 BEAVRS members were contacted by email in October 2014 requesting data on all cases treated with ocriplasmin up to that date. The total number of cases, FTMH closure rate, VMT release rate and the frequency of adverse events were recorded. Results were compared with trial data. Results 48 members responded reporting results from 241 eyes. The respective BEAVRS and MIVI TRUST trial closure rates for small FTMHs were 42.1 and 58.3% (P = 0.09) and for medium FTMH 12.7 and 36.7% (P = 0.01). The respective VMT release rates were 34.1 and 37.4% (P = NS). Retinal detachment was observed in 3.3% of the BEAVRS cohort compared with 0.4% in MIVI TRUST. Reduction in visual acuity to o6/60 was observed in 5.8% of the BEAVRS cohort and 0.6% in MIVI TRUST. Other complications not reported in the MIVI TRUST trial included an increase in FTMH basal diameter following unsuccessful ocriplasmin use in 46.9% of BEAVRS cases and zonular instability at the time of subsequent phacoemulsification in 2.4%. Conclusion Macular hole closure rates were lower in the BEAVRS survey than published in the MIVI TRUST trial data. The incidence of adverse events was greater than previously reported. The reasons for these disparities are unknown but could include positive reporting bias inherent to retrospective surveys, treatment and population differences.

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies

“…These results suggest that the known baseline factors predictive of VMA resolution, which were used as key inclusion criteria for the OASIS study, may be necessary but not sufficient to predict FTMH closure. Nevertheless, consistent with our findings, previous studies investigating FTMH closure rates following ocriplasmin treatment have repeatedly shown FTMH size at baseline to be the most consistent predictive factor, with a greater proportion of patients experiencing hole closure with an FTMH ≤ 250 m compared to those with an FTMH > 250-400 m. [14,36,37,44] In contrast, the natural history of untreated FTMH has revealed that spontaneous closure rates are low, ranging from 3-11%. [45][46][47][48][49] Although smaller holes have a comparatively better chance of spontaneous closure compared to larger ones, previous studies have shown that the majority of stage 2 macular holes (<400 m) progress to stage 3 and beyond if left untreated.…”

Idiopathic Macular Hole Preferred Practice Pattern®

“…The incidence of adverse events was also greater than previously reported. 168,170 The benefits and risks associated with vitrectomy surgery versus intravitreal ocriplasmin require continued investigation.…”

Multimodal imaging of macular subretinal deposits following intravitreal ocriplasmin injection

“…Sub-retinal fluid (SRF) following ocriplasmin intravitreal injection has been reported previously, particularly in eyes where traction has been successfully resolved. 6 , 8 , 10 , 13 , 14 , 15 , 16 , 17 Development of a serous detachment may be more common after ocriplasmin injection when compared to vitrectomy surgery. 18 Vitreomacular traction is rapidly resolved in vitrectomy surgery by peeling of the ILM with gas tamponade.…”

“…Electroretinogram (ERG) changes post-ocriplasmin injection have also been reported. 5 , 6 , 7 , 8 , 9 , 10 These findings raise questions regarding the potential diffuse retinal effects of ocriplasmin injection. Transient and long-term effects of ocriplasmin injection require further study.…”

“…1 , 3 , 4 Electroretinogram changes, dyschromatopsia and ellipsoid zone changes on SD-OCT following ocriplasmin injection have also been described. 5 , 6 , 7 , 8 , 9 , 10 …”