Gonzales John, Acharya Nisha R, Sugar Elizabeth A, Burke Alyce E, Vitale Albert T, Gupta Vishali, Dunn James P, Lightman Susan L, Thorne Jennifer E, Kim Rosa Y, Yeh Steven, Altaweel Michael M, Kempen John H, Holbrook Janet T, Jabs Douglas A
Francis. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Francis. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Departments of Epidemiology, University of California, San Francisco, San Francisco, California.
Ophthalmology. 2025 May;132(5):527-537. doi: 10.1016/j.ophtha.2024.11.021. Epub 2024 Nov 28.
Evaluation of longer-term effectiveness of 3 intravitreal therapies (methotrexate, ranibizumab, or dexamethasone implant) for participants enrolled in the randomized comparative effectiveness trial the Macular Edema Ranibizumab versus Intravitreal Anti-inflammatory Therapy (MERIT) Trial followed up for 24 weeks.
Multicenter randomized controlled clinical trial with masked evaluation of retinal thickness and visual acuity.
Patients with persistent or recurrent uveitic macular edema.
Participants from 33 centers were randomized 1:1:1 (stratified by presence or absence of concomitant systemic immunosuppression for uveitis) to receive a sequence of intravitreal treatments with dexamethasone implant, methotrexate, or ranibizumab. Participants with bilateral macular edema received the same treatment bilaterally. During 24 weeks of follow-up, nonassigned treatments were permitted beginning from 12 weeks for those meeting re-treatment criteria.
Central subfield thickness (CST) change from baseline OCT measurement was the main outcome. Secondary outcomes included change in mean standard letters of baseline best-corrected visual acuity (BCVA). Analyses were conducted according to 2 principles: (1) as assigned, in which outcomes were analyzed according to their original randomized treatment, and (2) a supplementary censored analysis, in which data were excluded after an eye received a nonassigned treatment.
Among 194 enrolled participants (225 eligible eyes), 177 participants (207 eyes) completed 24 weeks of follow-up. Eyes assigned to methotrexate (55%) and ranibizumab (37%) more frequently received nonassigned treatments (88% dexamethasone implant or intravitreal corticosteroid injection) compared with eyes assigned to dexamethasone (7%). In the as-assigned analysis, dexamethasone showed superior improvement in macular edema compared with ranibizumab (CST, 34% vs. 19%; P = 0.01), but not compared with methotrexate (CST, 31%; P = 0.59) after being superior to both other regimens at 12 weeks. However, in the censored analysis, only dexamethasone was associated with improvements in macular edema (CST, 34% vs 8% [P < 0.001] and 5% [P < 0.001]) and BCVA improvement of > 5 letters compared with methotrexate and ranibizumab, respectively. Dexamethasone more often was associated with intraocular pressure elevations of ≥ 24 mmHg (32%) and of ≥ 30 mmHg (10%).
Dexamethasone was more effective than methotrexate and ranibizumab for the treatment of persistent or recurrent uveitic macular edema through 24 weeks, with manageable side effects.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估三种玻璃体内治疗方法（甲氨蝶呤、雷珠单抗或地塞米松植入剂）对参加随机对照有效性试验“黄斑水肿雷珠单抗与玻璃体内抗炎治疗比较（MERIT）试验”并随访24周的参与者的长期有效性。
多中心随机对照临床试验，对视网膜厚度和视力进行盲法评估。
持续性或复发性葡萄膜炎性黄斑水肿患者。
来自33个中心的参与者按1:1:1随机分组（根据是否伴有葡萄膜炎全身免疫抑制进行分层），接受地塞米松植入剂、甲氨蝶呤或雷珠单抗的玻璃体内治疗序列。双侧黄斑水肿的参与者双侧接受相同治疗。在24周的随访期间，符合再治疗标准的参与者从第12周开始允许接受未分配的治疗。
基线光学相干断层扫描（OCT）测量的中心子野厚度（CST）变化是主要观察指标。次要观察指标包括基线最佳矫正视力（BCVA）平均标准字母数的变化。分析依据两个原则进行：（1）按分配方案，即根据最初随机分配的治疗分析结果；（2）补充删失分析，即一只眼接受未分配治疗后排除该眼的数据。
在194名入组参与者（225只符合条件的眼）中，177名参与者（207只眼）完成了24周的随访。与分配到地塞米松的眼（7%）相比，分配到甲氨蝶呤（55%）和雷珠单抗（37%）的眼更频繁地接受了未分配的治疗（88%为地塞米松植入剂或玻璃体内皮质类固醇注射）。在按分配方案分析中，地塞米松在黄斑水肿改善方面优于雷珠单抗（CST，34%对19%；P = 0.01），但与甲氨蝶呤相比无差异（CST，31%；P = 0.59），在12周时地塞米松优于其他两种治疗方案。然而，在删失分析中，与甲氨蝶呤和雷珠单抗相比，只有地塞米松与黄斑水肿改善相关（CST，34%对8%[P < 0.001]和5%[P < 0.001]）以及BCVA改善超过5个字母。地塞米松更常与眼压升高≥24 mmHg（32%）和≥30 mmHg（10%）相关。
地塞米松在治疗持续性或复发性葡萄膜炎性黄斑水肿方面比甲氨蝶呤和雷珠单抗更有效，且副作用可控，随访期达24周。
在本文末尾的脚注和披露中可能会发现专有或商业披露信息。
