Department of Ophthalmology, University of Bonn, Bonn, Germany.
Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19.
To investigate the efficacy and safety of intravitreal ranibizumab for the treatment of nonproliferative macular telangiectasia (MacTel) type 2.
Prospective, open-label, uncontrolled, nonrandomized interventional clinical trial.
One eye (disease stage 2 or 3) of each patient (n = 10) with nonproliferative MacTel type 2 was injected with 0.5 mg ranibizumab at monthly intervals for one year. Visual acuity, angiographic findings, and retinal thickness were assessed at each visit. The primary endpoint was the change in best-corrected distance visual acuity after one year compared to baseline.
Mean visual acuity showed a transient increase in the study eye. However, after 12 months of treatment there was no significant change of visual acuity compared to baseline or compared to the fellow eye. Fluorescein angiography revealed a decrease of telangiectatic-appearing capillaries and of late-phase leakage, which was accompanied by a topographically related significant reduction in macular thickness. Three to 5 months after the last treatment, angiographic appearance and retinal thickness were similar to baseline. In one patient, the last intravitreal injection was not performed because of safety concerns after a transitory ischemic attack. Otherwise, no serious adverse events were observed.
The angiographic and tomographic effects after intravitreal inhibition of vascular endothelial growth factor (VEGF) using ranibizumab implicate a pathophysiological role of the VEGF pathway in nonproliferative MacTel type 2. As the morphologic response was not associated with a clear functional benefit, and because of the transient nature of the treatment effect, monthly intravitreal ranibizumab is not recommended for the nonproliferative disease stage of MacTel type 2.
研究玻璃体内雷珠单抗治疗非增生性黄斑毛细血管扩张症 2 型（MacTel）的疗效和安全性。
前瞻性、开放标签、非对照、非随机干预性临床试验。
每位患者（n=10）的一只眼（疾病分期 2 或 3）接受每月间隔玻璃体内注射 0.5mg 雷珠单抗，持续一年。每次就诊时评估视力、血管造影结果和视网膜厚度。主要终点是与基线相比，一年后最佳矫正距离视力的变化。
研究眼的平均视力显示短暂增加。然而，治疗 12 个月后，与基线或对侧眼相比，视力没有显著变化。荧光素血管造影显示毛细血管扩张性毛细血管减少和晚期渗漏减少，这伴随着黄斑厚度的显著相关减少。最后一次治疗后 3-5 个月，血管造影外观和视网膜厚度与基线相似。在一名患者中，由于短暂性脑缺血发作后的安全问题，最后一次玻璃体内注射未进行。否则，未观察到严重不良事件。
玻璃体内抑制血管内皮生长因子（VEGF）后血管造影和断层扫描的效果表明 VEGF 通路在非增生性 MacTel 2 型中具有病理生理学作用。由于形态学反应与明确的功能益处无关，并且由于治疗效果的短暂性质，每月玻璃体内雷珠单抗不推荐用于 MacTel 2 型的非增生性疾病阶段。
