Importance Intravitreal anti–vascular endothelial growth factor (anti-VEGF) injections are used to treat a variety of posterior segment conditions, including some associated with glaucoma, such as macular edema due to central retinal vein occlusion (CRVO). Therefore, information regarding intraocular pressure (IOP)–related events associated with anti-VEGF therapies is important to help balance the risks and benefits over the course of therapy.

Objective To investigate IOP-related events among participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2).

Design, Setting, and Participants Secondary analysis of a randomized clinical trial that included 312 participants with macular edema secondary to CRVO or hemiretinal vein occlusion (HRVO) who were not taking IOP-lowering medications at baseline. First randomization occurred on September 14, 2014, and contained data through data freeze on April 1, 2020. Analysis took place from April 2020 through December 2020.

Interventions Study participants were initially randomized to 6 monthly intravitreal injections of aflibercept or bevacizumab. At month 6, protocol-defined good responders were rerandomized to continued monthly or treat-and-extend dosing of their originally assigned study drug, and protocol-defined poor or marginal responders were switched to alternative treatment. After month 12, participants were treated as per investigator discretion.

Main Outcomes and Measures Three different outcomes: (1) IOP elevation more than 10 mm Hg from baseline, (2) IOP to a level higher than 35 mm Hg, and (3) IOP-lowering incisional or laser surgery.

Results Of the 312 participants meeting inclusion criteria (138 [44.2%] were female; mean [SD] age, 67.8 [12.1] years), 25 (8.0%) had IOP elevation more than 10 mm Hg over baseline through month 60, and 5 (1.6%) had IOP higher than 35 mm Hg. The 60-month Kaplan-Meier cumulative incidence of IOP elevation more than 10 mm Hg over baseline was 0.13 (95% CI, 0.08-0.19), and the 60-month Kaplan-Meier cumulative incidence of IOP higher than 35 mm Hg was 0.02 (95% CI, 0.01-0.06), and did not differ among participants initially randomly assigned to receive aflibercept or bevacizumab. Three participants (1.0%) underwent IOP-lowering incisional surgery, and 3 participants (1.0%) underwent IOP-lowering glaucoma laser surgery.

Conclusions and Relevance Intravitreal anti-VEGF injections are used to treat some conditions associated with glaucoma, such as macular edema due to CRVO, and the rates of IOP-related events in this trial support monitoring IOP in eyes treated with anti-VEGF therapy for macular edema associated with CRVO or HRVO for up to 60 months.

Trial Registration ClinicalTrials.gov Identifier: NCT01969708

重要性 玻璃体内抗血管内皮生长因子 (anti-VEGF) 注射用于治疗多种后段疾病，包括一些与青光眼相关的疾病，例如视网膜中央静脉阻塞 (CRVO) 引起的黄斑水肿。因此，有关与抗 VEGF 治疗相关的眼压 (IOP) 相关事件的信息对于帮助平衡治疗过程中的风险和益处非常重要。

目的 调查视网膜静脉阻塞比较治疗研究 2 (SCORE2) 参与者的眼压相关事件。

设计、设置和参与者 一项随机临床试验的二次分析，该试验包括 312 名继发于 CRVO 或半视网膜静脉阻塞 (HRVO) 的黄斑水肿参与者，他们在基线时未服用降低眼压的药物。第一次随机化发生在 2014 年 9 月 14 日，包含 2020 年 4 月 1 日数据冻结的数据。分析发生在 2020 年 4 月至 2020 年 12 月。

干预 研究参与者最初被随机分配到玻璃体内注射阿柏西普或贝伐单抗 6 个月。在第 6 个月，方案定义的良好反应者被重新随机分配，继续每月或治疗和延长其最初分配的研究药物的剂量，而方案定义的差或边缘反应者被转换为替代治疗。12 个月后，根据研究者的判断对参与者进行治疗。

主要结果和测量 三种不同的结果：（1）眼压从基线升高超过 10 毫米汞柱，（2）眼压高于 35 毫米汞柱，以及（3）降低眼压的切口或激光手术。

结果 在符合纳入标准的 312 名参与者中（138 名 [44.2%] 为女性；平均 [SD] 年龄，67.8 [12.1] 岁），25 名（8.0%）在第 60 个月时眼压升高超过基线 10 mmHg，并且5 (1.6%) 的 IOP 高于 35 mm Hg。眼压升高超过基线 10 mm Hg 的 60 个月 Kaplan-Meier 累积发生率为 0.13（95% CI，0.08-0.19），眼压高于 35 mm Hg 的 60 个月 Kaplan-Meier 累积发生率为 0.02 (95% CI, 0.01-0.06)，并且在最初随机分配接受阿柏西普或贝伐单抗的参与者之间没有差异。3 名参与者 (1.0%) 接受了降低眼压的切口手术，3 名参与者 (1.0%) 接受了降低眼压的青光眼激光手术。

结论和相关性 玻璃体内抗 VEGF 注射用于治疗与青光眼相关的一些疾病，例如 CRVO 引起的黄斑水肿，该试验中眼压相关事件的发生率支持监测接受抗 VEGF 治疗黄斑的眼的眼压与 CRVO 或 HRVO 相关的水肿长达 60 个月。

试验注册 ClinicalTrials.gov 标识符：NCT01969708