Intravitreal ocriplasmin for the treatment of vitreomacular traction and macular hole- A study of efficacy and safety based on NICE guidance

Purpose
To evaluate the real world clinical outcomes of intravitreal ocriplasmin in patients with vitreomacular traction (VMT) with and without full thickness macular holes (FTMH) treated according to NICE guidance.
Methods
Retrospective observational case series of 25 patients treated with a single intravitreal ocriplasmin injection between December 2013 and December 2015. Best corrected visual acuity and optical coherence tomography exams were performed to determine visual outcomes and anatomical VMT release and FTMH closure over time. Two patient groups were identified: ocular macular co-morbidity (OCM) and no OCM (nOCM), with follow-up at 4, 12, and 24 weeks.
Results
Twenty-five patients were identified that included 19 patients with VMT, and 6 patients with VMT plus FTMH. In the nOCM group of 22 patients, the release rate of VMT was 44%, 63%, and 69% at 4, 12 and 24 weeks respectively. In the “real-world” OCM group of 25 patients, the VMT release rate was 37%, 53%, and 58% at the same time-points. In both groups, the FTMH closure rate was 33%, 50%, and 67% at 4, 12, and 24 weeks. At mean follow-up of 30 weeks in the VMT group with nOCM, the mean LogMAR VA improved significantly from 0.44 to 0.28 (p = 0.0068, paired t-test). Three were no serious adverse events.
Conclusions
This study reports improved efficacy of intravitreal ocriplasmin for both VMT and FTMH, and is more favourable in patients with no ocular co-morbidity. We highlight the importance of careful patient selection and structured standard of care pathways to identify patients who will benefit from the positive visual and anatomical effects of intravitreal ocriplasmin.

研究目的：评估按照英国国家卫生与临床优化研究所（National Institute for Health and Care Excellence, NICE）指南治疗的、合并或不合并全层黄斑裂孔（full thickness macular holes, FTMH）的玻璃体黄斑牵拉综合征（vitreomacular traction, VMT）患者，接受玻璃体内奥克纤溶酶（intravitreal ocriplasmin）治疗后的真实世界临床结局。
研究方法：本研究为回顾性观察性病例系列，纳入2013年12月至2015年12月期间接受单次玻璃体内奥克纤溶酶注射治疗的25例患者。通过最佳矫正视力检测与光学相干断层扫描（optical coherence tomography, OCT）检查，评估随时间推移的视力结局、解剖层面的玻璃体黄斑牵拉松解及全层黄斑裂孔闭合情况。将患者分为两类：合并眼部黄斑合并症（ocular macular co-morbidity, OCM）组与无眼部黄斑合并症（no OCM, nOCM）组，并分别在治疗后4周、12周及24周进行随访。
研究结果：本研究共纳入25例患者，其中19例为单纯玻璃体黄斑牵拉综合征患者，6例为合并全层黄斑裂孔的玻璃体黄斑牵拉综合征患者。在22例无眼部黄斑合并症组中，治疗后4周、12周及24周的玻璃体黄斑牵拉松解率分别为44%、63%及69%；在25例真实世界队列的眼部黄斑合并症组中，对应时间点的玻璃体黄斑牵拉松解率分别为37%、53%及58%。两组患者的全层黄斑裂孔闭合率在治疗后4周、12周及24周分别为33%、50%及67%。在平均随访30周的无眼部黄斑合并症玻璃体黄斑牵拉综合征亚组中，患者的平均最小分辨角对数视力（Logarithm of the Minimum Angle of Resolution Visual Acuity, LogMAR VA）从0.44显著提升至0.28（配对t检验，p=0.0068）。本研究未发生严重不良事件。
研究结论：本研究证实，玻璃体内奥克纤溶酶治疗玻璃体黄斑牵拉综合征及全层黄斑裂孔均具有良好疗效，且在无眼部合并症的患者中效果更优。本研究强调，需严格筛选患者并遵循标准化诊疗流程，以甄别出可从玻璃体内奥克纤溶酶治疗的视力与解剖学获益中获益的人群。