Wills Eye Institute, Philadelphia, Pennsylvania 19107, USA.
Ophthalmology. 2011 Dec;118(12):2453-60. doi: 10.1016/j.ophtha.2011.05.014. Epub 2011 Jul 20.
To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO).
Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension.
We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO.
At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250 μm.
The primary outcome for the open-label extension was safety; BCVA was also evaluated.
At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively.
Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估玻璃体内注射地塞米松植入物（DEX 植入物）1 或 2 次治疗，在 12 个月内对因分支或中央视网膜静脉阻塞（BRVO 或 CRVO）引起的黄斑水肿的安全性和疗效。
两项相同的、多中心、前瞻性研究包括一个随机、6 个月、双盲、假对照阶段，随后是 6 个月的开放标签扩展。
我们纳入了 1256 名因 BRVO 或 CRVO 相关黄斑水肿导致视力丧失的患者。
在基线时，患者在研究眼中接受 DEX 植入物 0.7mg（n=421）、DEX 植入物 0.35mg（n=412）或假（n=423）。在第 180 天，如果最佳矫正视力（BCVA）<84 个字母或视网膜厚度>250μm，患者可以接受 DEX 植入物 0.7mg。
开放标签延伸的主要结果是安全性；还评估了 BCVA。
在第 180 天，997 名患者接受了开放标签 DEX 植入物。除了白内障外，接受第一次或第二次 DEX 植入的患者眼部不良事件的发生率相似。在 12 个月内，2 次接受 0.7mg DEX 植入的 302 只未白内障眼中有 90 只（29.8%）发生白内障进展，而 88 只假治疗未白内障眼中有 5 只（5.7%）；分别有 4 只（1.3%）和 1 只（1.1%）眼接受了白内障手术。在接受两次 0.7mg DEX 植入的组（n=341）中，从基线开始，眼压（IOP）升高≥10mmHg的比例为（第一次治疗后 12.6%，第二次治疗后 15.4%）。眼压升高通常是短暂的，并通过药物治疗或观察控制；第二次治疗后，另外 10.3%的患者开始使用降眼压药物。在第一次和第二次 DEX 植入后 60 天，分别有 30%和 32%的患者 BCVA 较基线提高≥15 个字母。
在因 BRVO 或 CRVO 引起的黄斑水肿患者中，玻璃体内注射 DEX 植入物在 12 个月内具有良好的安全性。在有资格接受并接受 2 次 DEX 植入物注射的患者中，除了白内障进展外，两次植入物的疗效和安全性相似。
参考文献后可能有专有或商业披露。
