Department of Ophthalmology, Hôpital Lariboisière (AP-HP), Université Paris 7 (Sorbonne Paris Cité), Paris, France.
Department of Ophthalmology, University of Bonn, Bonn, Germany.
Retina. 2019 Dec;39(12):2341-2352. doi: 10.1097/IAE.0000000000002332.
To evaluate the anatomical and functional outcomes with ocriplasmin in patients with vitreomacular traction (VMT) with or without macular hole (MH).
In a Phase 4, multicenter, single-arm, open-label study, eligible patients (VMT with focal adhesion, without epiretinal membrane, and with MH ≤400 µm [if present]) received a single intravitreal injection of ocriplasmin. Nonsurgical resolution of VMT (Day 28 [primary endpoint]), best-corrected visual acuity, MH closure, vitrectomy rate, and safety were assessed through Day 180.
Overall, 466 patients were included in the full analysis set, of whom 47.4% had VMT resolution by Day 28; resolution rates in patients with VMT without MH, VMT with MH ≤250 µm, and VMT with MH >250 to ≤400 µm were 43.4%, 68.6%, and 62.7%, respectively. Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28. Overall, 30.8% of patients with VMT resolution gained ≥10 letters in best-corrected visual acuity at Day 180. Adverse events were consistent with the known safety profile of ocriplasmin.
Ocriplasmin is effective for resolution of VMT without or with MH (≤400 μm); treatment outcomes can be optimized with patient selection.
评估维替泊芬治疗伴有或不伴有黄斑孔（MH）的玻璃体黄斑牵拉（VMT）患者的解剖和功能结果。
在一项 4 期、多中心、单臂、开放性标签研究中，符合条件的患者（伴有局灶性黏附的 VMT，无视网膜前膜，且 MH≤400µm[如果存在]）接受单次玻璃体内注射维替泊芬。通过第 28 天（主要终点）评估 VMT 非手术缓解、最佳矫正视力、MH 闭合、玻璃体切除术率和安全性。
总体而言，共有 466 例患者纳入全分析集，其中 47.4%的患者在第 28 天达到 VMT 缓解；无 MH 的 VMT、MH≤250µm 的 VMT 和 MH＞250µm 至≤400µm 的 VMT 的缓解率分别为 43.4%、68.6%和 62.7%。第 28 天，伴有 VMT 和 MH≤250µm 的眼 MH 闭合率（57.1%）高于伴有 VMT 和 MH＞250µm 至≤400µm 的眼（27.5%）。总体而言，30.8%的 VMT 缓解患者在第 180 天最佳矫正视力提高≥10 个字母。不良事件与维替泊芬已知的安全性特征一致。
维替泊芬可有效治疗伴有或不伴有 MH（≤400µm）的 VMT；通过患者选择可优化治疗效果。
