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雷珠单抗治疗与年龄相关的黄斑变性的色素上皮脱离:一项前瞻性研究。

RANIBIZUMAB IN PIGMENT EPITHELIAL TEARS SECONDARY TO AGE-RELATED MACULAR DEGENERATION: A Prospective Study.

机构信息

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Department of Ophthalmology, University of Münster, Münster, Germany.

出版信息

Retina. 2019 Dec;39(12):2369-2377. doi: 10.1097/IAE.0000000000002311.

Abstract

PURPOSE

To assess efficacy of intravitreal ranibizumab in retinal pigment epithelium tears secondary to neovascular age-related macular degeneration.

METHODS

The Ranibizumab In Pigment epithelial tears secondary to age-related macular degeneration (RIP) study is a prospective, single-arm, multicenter, investigator-initiated trial. Twenty four eyes of 24 patients with a retinal pigment epithelium tear secondary to age-related macular degeneration received monthly intravitreal injection of 0.5mg ranibizumab for 12 months, together with monthly assessments of morphologic and functional efficacy parameters. Primary outcome measure was mean best-corrected visual acuity at final visit compared with baseline.

RESULTS

Mean best-corrected visual acuity remained stable over the 12-month study period with 50.3 Early Treatment of Diabetic Retinopathy Study letters (±18.7; Snellen equivalent 20/100) at baseline and 52.9 letters (±19.7; Snellen equivalent 20/100) at final visit (P = 0.39). One eye (4%) experienced a vision loss of ≥15 letters, and 2 eyes (8%) gained ≥15 letters. Mean central retinal thickness decreased from 571 µm (±185 µm) to 436 µm (±171 µm; P = 0.0001). Vision-related quality of life was stable with a mean VFQ-25 score of 79.0 (±10.8) at baseline and 74.3 (±13.9) at final visit (P = 0.12).

CONCLUSION

In retinal pigment epithelium tears secondary to age-related macular degeneration, monthly intravitreal ranibizumab therapy results in stabilization of visual acuity over 12 months.

摘要

目的

评估玻璃体内雷珠单抗治疗新生血管性年龄相关性黄斑变性伴视网膜色素上皮撕裂的疗效。

方法

雷珠单抗治疗年龄相关性黄斑变性伴视网膜色素上皮撕裂(RIP)研究是一项前瞻性、单臂、多中心、研究者发起的临床试验。24 例(24 只眼)年龄相关性黄斑变性伴视网膜色素上皮撕裂患者接受每月玻璃体内注射 0.5mg 雷珠单抗,共 12 个月,同时每月评估形态和功能疗效参数。主要观察指标为最终随访时平均最佳矫正视力与基线相比的变化。

结果

在 12 个月的研究期间,平均最佳矫正视力保持稳定,基线时为 50.3 个早期治疗糖尿病视网膜病变研究字母(±18.7;Snellen 等效值 20/100),最终随访时为 52.9 个字母(±19.7;Snellen 等效值 20/100)(P=0.39)。1 只眼(4%)视力损失≥15 个字母,2 只眼(8%)视力增加≥15 个字母。中央视网膜厚度从 571μm(±185μm)降至 436μm(±171μm;P=0.0001)。视功能相关生活质量稳定,基线时平均视觉功能问卷 25 项(VFQ-25)得分为 79.0(±10.8),最终随访时为 74.3(±13.9)(P=0.12)。

结论

在年龄相关性黄斑变性伴视网膜色素上皮撕裂中,每月玻璃体内雷珠单抗治疗可使视力在 12 个月内稳定。

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