Schiff William M, Hwang John C, Ober Michael D, Olson Jeffrey L, Dhrami-Gavazi Elona, Barile Gaetano R, Chang Stanley, Mandava Naresh
Department of Ophthalmology, Edward S. Harkness Eye Institute, College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Arch Ophthalmol. 2007 Sep;125(9):1161-7. doi: 10.1001/archopht.125.9.1161.
To determine the safety and efficacy of VIT100 (Immusol, Inc, San Diego, California), a ribozyme to proliferating cell nuclear antigen, in preventing recurrent proliferative vitreoretinopathy (PVR) in patients with established PVR who undergo vitrectomy for retinal reattachment repair.
A multicenter, double-masked, placebo-controlled, randomized clinical trial. One hundred seventy-five eyes from 175 patients with grade C or worse PVR were randomly assigned to receive high-dose VIT100, low-dose VIT100, or placebo by intravitreal injection at the conclusion of retinal reattachment surgery.
The primary efficacy end point was recurrent retinal detachment secondary to PVR. The secondary end point was recurrent retinal detachment due to any cause.
One hundred fifty-four patients completed the study. Forty-one patients (27%) developed recurrent retinal detachment due to PVR by 24 weeks, including 18 patients (33%) in the group receiving 0.75 mg, 13 patients (24%) in the group receiving 0.15 mg, and 10 patients (22%) in the placebo group. There was no statistically significant difference in patients reaching this end point by 24 weeks (P = .37). Ancillary statistical analyses are reported.
VIT100 was not effective in preventing PVR recurrence in patients with established grade C or worse PVR.
To our knowledge, this is the most recent, meticulously designed clinical trial in PVR.
确定VIT100（Immusol公司，加利福尼亚州圣地亚哥），一种针对增殖细胞核抗原的核酶，在接受玻璃体切除术以修复视网膜脱离的已确诊增殖性玻璃体视网膜病变（PVR）患者中预防PVR复发的安全性和有效性。
一项多中心、双盲、安慰剂对照、随机临床试验。175例患有C级或更严重PVR的患者的175只眼睛在视网膜复位手术结束时通过玻璃体内注射被随机分配接受高剂量VIT100、低剂量VIT100或安慰剂。
主要疗效终点是继发于PVR的复发性视网膜脱离。次要终点是由任何原因导致的复发性视网膜脱离。
154例患者完成了研究。41例患者（27%）在24周时因PVR出现复发性视网膜脱离，其中接受0.75mg的组中有18例患者（33%），接受0.15mg的组中有13例患者（24%），安慰剂组中有10例患者（22%）。到24周时达到该终点的患者之间无统计学显著差异（P = 0.37）。报告了辅助统计分析。
VIT100在预防已确诊C级或更严重PVR患者的PVR复发方面无效。
据我们所知，这是PVR领域最新、设计精心的临床试验。
