Clinical researchers at the Department of Ophthalmology, St. Joseph’s Hospital, London, Ontario have reported that a systematic review and meta-analysis between pars plana vitrectomy to ocriplasmin showed 92% macular hole closure after surgery compared to 34% after ocriplasmin treatment. Canadian researchers outlined that the study was the first systematic review to analyze literature on the effects of ocriplasmin and vitrectomy as treatment for macular holes (MH). The three principal outcome measurements included MH closure rate, the change in the MH size and visual acuity.
The systematic review evaluated 261 studies, of which 26 were included studies for meta-analysis. The research recorded studies in multiple countries including the USA, Canada, UK, Belgium, Germany, Czech Republic and France. In a breakdown of the publications, six (6) studies were randomized controlled trials (RCT), four (4) studies were retrospective analyses, seven (7) studies were retrospective reviews, four (4) studies were retrospective studies, four (4) further studies were retrospective case series, and one (1) study was a prospective study. Data on the results reported a significant reduction in post-operative MH size after PPV (SMD = −2.64; CI: [−3.01, −2.26]), p = 0.045, including heterogeneity I2 = 67.8% of meta-analysis. The previous data from the original sponsor highlighted that pooled results from clinical research showed that enzymatic vitreolysis resolved vitreomacular adhesion (VMA) and full thickness macular hole (FTMH), without the need for surgery. The results reported that 26.4% of the 465 treated patients achieved resolution of their VMA at 28 days, compared to 10.2% of the 182 patients who received a placebo injection. In patients without epiretinal membrane, the treatment was shown to be more effective, with 37.4% of 270 patients achieving nonsurgical resolution of their VMA at 28 days, compared to 14.3% of 119 placebo treated patients. In patients diagnosed with full thickness macular hole, 40.6% of 106 patients saw closure of the FTMH at 28 days following a single 125ug injection without the need for a vitrectomy. This compares with 10.6% of 47 patients in the placebo group.
However, while the systematic review shows the topline outcome for surgery, the study also showed that there was a significant improvement in visual acuity (VA) of patients seen after both PPV and vitreolytic treatments. The VA results showed significant improvement in post-operative vision after PPV for SMD = −1.42; CI: [−1.98, −0.86]), compared to the ocriplasmin for SMD = −0.73; CI: [−0.98, −0.48]). This showed there was a significant improvement in vision occurred after both the treatments. As a consequence, the researchers also concluded that “more good quality randomized controlled trials are required to make strong conclusions”.