Ophthalmic Surg Lasers Imaging Retina. 2020 Mar 1;51(3):170-178. doi: 10.3928/23258160-20200228-06.
To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema (ME) following cataract surgery.
This phase 2, prospective, interventional, single-masked, randomized trial at a single academic center included 30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main outcome measures included treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities as detected by optical coherence tomography at any follow-up visit), a 30% or greater increase from preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters from Day 7 due to retinal thickening.
There were similar incidences of AEs between the two groups and no clinically serious ocular AEs in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161). Compared to the study group, the control group had a significantly greater increase in central subfield thickness (CST) at Day 30 (50.05 μm vs. 7.95 μm; P = .040) and Day 60 (56.45 μm vs. 3.02 μm; P = .010). However, the difference in CST between groups was no longer significant at Day 90 (50.31 μm vs. 18.48 μm; P = .12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 8.52; P = .66).
Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant AEs. Although there were significant differences in ME incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of VA. Further larger trials are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:170-178.].
评估玻璃体内注射阿柏西普（IAI）治疗糖尿病视网膜病变（DR）患者白内障术后黄斑水肿（ME）的安全性和有效性。
该单中心、前瞻性、干预性、单盲、随机试验纳入 30 例年龄在 18 岁及以上的非增殖性 DR 患者，这些患者接受白内障超声乳化术。患者在白内障手术期间接受 2mg 玻璃体内注射阿柏西普（0.05mL）或假注射。主要观察指标包括治疗不良事件（AE）、最佳矫正视力（BCVA）和 ME 发生率（定义为在任何随访时光学相干断层扫描检测到的囊样异常）、中央视网膜厚度较术前基线增加 30%或以上、或因视网膜增厚导致术后 7 天 BCVA 下降超过 5 个 ETDRS 字母。
两组的 AE 发生率相似，且两组均无严重眼部 AE。IAI 组在第 14 天（13%比 53%；P=.022）和第 30 天（27%比 60%；P=.057）、第 60 天（27%比 60%；P=.057）和第 90 天（40%比 67%；P=.161）的 ME 事件发生率较低，但无显著差异。与研究组相比，对照组在第 30 天（50.05μm比 7.95μm；P=.040）和第 60 天（56.45μm比 3.02μm；P=.010）的中央视网膜厚度（CST）增加更为显著。然而，第 90 天两组间 CST 的差异不再具有统计学意义（50.31μm比 18.48μm；P=.12）。在随访结束时（第 90 天，ETDRS 字母：9.88 比 8.52；P=.66），IAI 组与假手术组的 BCVA 增益无显著差异。
在白内障术后 ME 的预防中，DR 患者使用 IAI 治疗未显示出明显的 AE。尽管在 ME 发生率和视网膜厚度方面存在显著差异，但在 VA 方面没有明显的临床获益。需要进一步的大规模试验来验证这些发现。
