Department of Ophthalmology, University of Cologne, Cologne, Germany; Cologne Ophthalmological Reading and Image Analysis Center (CORIC), University of Cologne, Cologne, Germany.
Department of Ophthalmology, University of Cologne, Cologne, Germany.
Ophthalmology. 2014 Sep;121(9):1677-82. doi: 10.1016/j.ophtha.2014.03.016. Epub 2014 Apr 26.
To test whether subconjunctival cyclosporine A (CsA) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty.
Prospective, randomized, multicenter, controlled phase 2/3 clinical trial. The study comprised 43 trial sites in Germany, India, and the United States.
Enrolled patients (n = 97) were randomized to 1 of 3 groups: treatment group A (n = 36), treatment group B (n = 40), and the control group (n = 21).
Patients from each group received either of 2 doses of subconjunctival CsA (group A, low-dose CsA; group B, high-dose CsA) or placebo (carrier only) implants at the time of high-risk penetrating keratoplasty.
The incidence and degree of corneal neovascularization occurring after penetrating keratoplasty were evaluated in a substudy (LX201-01 study: NCT00447187). A web-based image upload system was developed. Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using CellˆF morphometry software.
No statistically significant difference in incidence and degree of corneal neovascularization developing after penetrating keratoplasty was found between treatment groups and placebo group. Mean corneal neovascularization area at week 52 (visit 12) was 2.32±1.79% in treatment group A versus placebo (2.79±2.11%; P = 0.45) and 2.74±2.22% in treatment group B versus placebo (2.79±2.11%; P = 0.94).
High-dose subconjunctival CsA implants do not significantly affect corneal neovascularization after high-risk penetrating keratoplasty. This suggests that local CsA has negligible antiangiogenic effects in the human cornea, at least in the transplant setting.
检测球结膜下环孢素 A（CsA）植入物是否会影响穿透性角膜移植术后角膜新生血管的发生率和程度。
前瞻性、随机、多中心、对照 2/3 期临床试验。该研究包括德国、印度和美国的 43 个试验点。
入组患者（n=97）随机分为 3 组：治疗组 A（n=36）、治疗组 B（n=40）和对照组（n=21）。
每组患者均在高危穿透性角膜移植时接受 2 剂球结膜下 CsA（A 组：低剂量 CsA；B 组：高剂量 CsA）或安慰剂（仅载体）植入物。
穿透性角膜移植术后角膜新生血管的发生率和程度在亚研究（LX201-01 研究：NCT00447187）中进行评估。开发了一个基于网络的图像上传系统。使用 CellˆF 形态计量软件对标准化数字裂隙灯照片进行定量和客观评估。
治疗组与安慰剂组之间穿透性角膜移植术后角膜新生血管的发生率和程度无统计学差异。第 52 周（访视 12）时治疗组 A 的平均角膜新生血管面积为 2.32±1.79%，安慰剂组为 2.79±2.11%（P=0.45），治疗组 B 为 2.74±2.22%，安慰剂组为 2.79±2.11%（P=0.94）。
高剂量球结膜下 CsA 植入物不会显著影响高危穿透性角膜移植术后的角膜新生血管形成。这表明局部 CsA 在人类角膜中至少在移植环境中具有可忽略的抗血管生成作用。
