University of Texas Medical Branch College of Medicine, Galveston, TX, USA.
Department of Ophthalmology, University of Texas Medical Branch, Galveston, TX, USA.
Middle East Afr J Ophthalmol. 2024 Sep 13;30(3):141-148. doi: 10.4103/meajo.meajo_17_22. eCollection 2023 Jul-Sep.
The purpose of this study was to report the visual and anatomic results at 12 and 24 months using the protocol of 3 monthly (PRN) injections for diabetic macular edema (DME).
This was a retrospective chart review of 97 eyes with DME treated with a protocol of cycles consisting of 3 monthly injections of anti-vascular endothelial growth factor drugs on a PRN basis. Change in visual acuity was the main outcome measure. Macular thickness, number of injections, cycles, and visits in years 1 and 2 of follow-up were secondary outcomes.
Ninety-six patients with a mean age of 60.9 ± 9.96 years were followed for a mean of 22.17 ± 12.30 months. Ninety-two (95.9%), 3 (3%), and 1 (1%) patients were started on bevacizumab, ranibizumab, and aflibercept, respectively. Of bevacizumab patients, 17 (18.2%) were eventually switched to aflibercept. The mean 12-month improvement (standard deviation [SD]) was + 3.3 (17.4) letters (95% confidence interval [CI] = +0.36-+7.05, < 0.001) after an average (SD) of 5.97 (2.98) injections over a mean (SD) of 1.7 (1.0) three-injection cycles. The mean 24-month improvement (SD) was + 5.6 (13.0) letters (95% CI: -0.28-11.05, = 0.0186) after an average (SD) of 8.72 (6.31) injections over a mean (SD) of 2.9 (2.1) three-injection cycles. The mean central macular thickness (SD) at baseline, 12 months, and 24 months was 374 ± 120, 322 ± 88, and 305 ± 70 µm. Optical coherence tomography was fluid free at 12 and 24 months in 27.6% and 46% of eyes, respectively.
Comparable to real-world studies, this protocol can stabilize or improve vision in more than 85% of DME patients over 24 months. The most important factor in improvement of vision is increasing number of injections and visits.
本研究旨在报告采用每 3 个月（PRN）注射方案治疗糖尿病黄斑水肿（DME）的 12 个月和 24 个月时的视力和解剖学结果。
这是一项回顾性图表研究，纳入了 97 只接受 DME 治疗的眼睛，这些眼睛接受了包含 3 个月注射周期的方案治疗，这些周期基于 PRN 原则使用抗血管内皮生长因子药物。视力变化是主要观察指标。黄斑厚度、注射次数、周期数以及第 1 年和第 2 年的就诊次数是次要观察指标。
96 例患者的平均年龄为 60.9±9.96 岁，平均随访时间为 22.17±12.30 个月。分别有 92（95.9%）、3（3%）和 1（1%）例患者开始接受贝伐单抗、雷珠单抗和阿柏西普治疗。贝伐单抗患者中，17 例（18.2%）最终转为阿柏西普治疗。在平均接受 5.97（2.98）次注射、平均进行 1.7（1.0）个 3 次注射周期后，12 个月时平均（标准差）视力提高了+3.3（17.4）个字母（95%置信区间[CI]：+0.36 至+7.05，<0.001）。24 个月时，平均（标准差）视力提高了+5.6（13.0）个字母（95%CI：-0.28 至+11.05，=0.0186），平均接受 8.72（6.31）次注射、平均进行 2.9（2.1）个 3 次注射周期。基线时、12 个月和 24 个月时的平均中央黄斑厚度（标准差）分别为 374±120、322±88 和 305±70µm。12 个月和 24 个月时，分别有 27.6%和 46%的眼 OCT 检查结果为无液。
与真实世界研究相比，该方案在 24 个月内可使超过 85%的 DME 患者的视力稳定或改善。视力改善的最重要因素是增加注射次数和就诊次数。
