California Retina Research Foundation, Santa Barbara, California, USA.
Retina. 2011 Jun;31(6):1060-7. doi: 10.1097/IAE.0b013e3181fbce76.
To evaluate the safety and efficacy of intravitreal ranibizumab for macular edema secondary to central retinal vein occlusion.
Patients with macular edema secondary to perfused central retinal vein occlusion were enrolled in this ongoing, prospective, open-label study. Treatment was initiated with monthly intravitreal ranibizumab for 3 months. In the first year, additional injections were administered for edema in quarterly intervals as needed (PRN) for Cohort 1 (n = 10) and monthly PRN for Cohort 2 (n = 10). In the second year of treatments, all patients received monthly PRN treatment. Early Treatment Diabetic Retinopathy Study best-corrected visual acuity, central retinal thickness, fundus photographs, and fluorescein angiograms were evaluated, and the incidence and severity of adverse events were documented.
Mean change in best-corrected visual acuity and central retinal thickness improved during the induction phase in both groups. During the remainder of the first year for Cohort 1, initial gains were lost during quarterly treatment but returned with monthly PRN treatment in the second year. For Cohort 2, improvement in best-corrected visual acuity and central retinal thickness from the induction phase was maintained through Month 24. Nineteen of 20 patients experienced a reduction in intraretinal hemorrhage, optic nerve swelling, and/or venous diameter after treatment. One myocardial infarction, one cerebrovascular accident, and no serious ocular adverse events were reported. Iris neovascularization was developed in none of the eyes.
Ranibizumab was well tolerated and associated with a greater reduction in macular edema and improvement in visual acuity in the monthly PRN regimen compared with quarterly treatment. Vision lost during the quarterly PRN injection intervals in the first year of Cohort 1 could be regained by switching to monthly PRN dosing.
评估玻璃体内雷珠单抗治疗视网膜中央静脉阻塞继发黄斑水肿的安全性和有效性。
本研究为正在进行的前瞻性、开放性研究,纳入视网膜中央静脉阻塞伴黄斑水肿患者。治疗初始每月玻璃体腔内注射雷珠单抗 3 个月,第 1 年,第 1 队列(n=10)根据需要(PRN)每 3 个月,第 2 队列(n=10)每月 PRN 注射;第 2 年所有患者每月 PRN 治疗。评估早期治疗糖尿病视网膜病变研究最佳矫正视力、中心视网膜厚度、眼底照片和荧光素血管造影,并记录不良事件的发生率和严重程度。
两组诱导期最佳矫正视力和中心视网膜厚度均有改善。第 1 年第 1 队列的季度治疗期间,初始改善丢失,但第 2 年每月 PRN 治疗后恢复。第 2 队列,从诱导期开始的最佳矫正视力和中心视网膜厚度改善持续到第 24 个月。19/20 例患者视网膜内出血、视神经肿胀和/或静脉直径减小。1 例心肌梗死,1 例脑血管意外,无严重眼部不良事件。所有患者虹膜新生血管均未发生。
雷珠单抗治疗耐受性良好,与每 3 个月治疗相比,每月 PRN 方案可使黄斑水肿减轻更多,视力提高更明显。第 1 年第 1 队列的季度 PRN 注射间隔期间视力丧失可通过切换为每月 PRN 剂量恢复。