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ETDRS 全视网膜光凝联合玻璃体内雷珠单抗与 PASCAL 全视网膜光凝联合玻璃体内雷珠单抗与单纯玻璃体内雷珠单抗治疗增生性糖尿病视网膜病变。

ETDRS panretinal photocoagulation combined with intravitreal ranibizumab versus PASCAL panretinal photocoagulation with intravitreal ranibizumab versus intravitreal ranibizumab alone for the treatment of proliferative diabetic retinopathy.

机构信息

Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.

Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.

出版信息

Arq Bras Oftalmol. 2020 Nov-Dec;83(6):526-534. doi: 10.5935/0004-2749.20200096.

Abstract

PURPOSE

To compare visual acuity, macular thickness, and the area of active neovascularization based on fluorescein angiography outcomes associated with standard single-spot panretinal photocoagulation in the Early Treatment Diabetic Retinopathy Study (ETDRS) pattern combined with intravitreal ranibizumab injection versus multiple-spot full scatter (PASCAL) panretinal photocoagulation combined with intravitreal ranibizumab injection versus intravitreal injection alone in patients with proliferative diabetic retinopathy.

METHODS

Patients with proliferative diabetic retinopathy and no prior laser treatment were randomly assigned to receive three different types of treatment. Panretinal photocoagulation in the ETDRS group was administered in two sessions (weeks 0 and 2), and panretinal photocoagulation in the PASCAL group was administered in one session (week 0). Intravitreal injection of ranibizumab was administered at the end of the first laser session in both the ETDRS and PASCAL groups and at week 0 in the intravitreal injection group. Comprehensive ophthalmic evaluations were performed at baseline and every 4 weeks through week 48.

RESULTS

Thirty patients (n=40 eyes) completed the 48-week study period. After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group. A significant decrease in central subfield macular thickness was observed in the PASCAL group at weeks 4, 8, and 48; only at week 48 in the intravitreal injection group; and never in the ETDRS group. There was no significant difference among the three treatment groups with respect to change from baseline to week 48 in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization.

CONCLUSIONS

Intravitreal injection alone or combined with single- or multiple-spot panretinal photocoagulation yielded similar outcomes with respect to mean change in best-corrected visual acuity, central subfield macular thickness, and fluorescein leakage from active neovascularization at up to one-year of follow-up. All subjects provided written informed consent to participate (NCT02005432 in clinicaltrials.gov).

摘要

目的

比较基于荧光素血管造影结果的视力、黄斑厚度和活跃新生血管面积,这些结果与标准的单部位全视网膜光凝(ETDRS 模式)联合玻璃体内雷珠单抗注射、多点全散射(PASCAL)全视网膜光凝联合玻璃体内雷珠单抗注射与玻璃体内注射单独治疗增殖型糖尿病视网膜病变患者的效果相关。

方法

将未经激光治疗的增殖型糖尿病视网膜病变患者随机分为三组,分别接受三种不同的治疗方式。ETDRS 组行两次全视网膜光凝(第 0 周和第 2 周),PASCAL 组行一次全视网膜光凝(第 0 周)。两组患者均在首次激光治疗结束时(第 0 周)和玻璃体内注射组在第 0 周时给予玻璃体内注射雷珠单抗。在基线和第 4 周后,每 4 周进行一次全面的眼科评估,直到第 48 周。

结果

30 例(40 只眼)患者完成了 48 周的研究。治疗后,单独玻璃体内注射组在所有随访时间点的最佳矫正视力均显著(p<0.05)提高,ETDRS 组在所有时间点(第 4 周除外)和 PASCAL 组在所有时间点(第 4 周和第 8 周除外)的最佳矫正视力均显著提高。PASCAL 组在第 4、8 和 48 周时中央视网膜黄斑厚度显著下降,而玻璃体内注射组仅在第 48 周时中央视网膜黄斑厚度显著下降,ETDRS 组则从未下降。从基线到第 48 周,三组治疗在最佳矫正视力、中央视网膜黄斑厚度或荧光素渗漏方面的变化没有显著差异。

结论

在长达一年的随访中,单独玻璃体内注射或联合单部位或多点全视网膜光凝在最佳矫正视力、中央视网膜黄斑厚度和荧光素渗漏方面的平均变化方面,结果相似。所有患者均签署了书面知情同意书参与本研究(NCT02005432 号,clinicaltrials.gov)。

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