Dugel Pravin U, Capone Antonio, Singer Michael A, Dreyer Richard F, Dodwell David G, Roth Daniel B, Shi Rui, Walt John G, Scott Lanita C, Hollander David A
Retinal Consultants of Arizona, 1101 E. Missouri Avenue, P.O. Box 32530, Phoenix, AZ, 85014-2709, USA.
Associated Retinal Consultants, Novi, MI, USA.
BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.
Dexamethasone intravitreal implant (DEX implant) is a biodegradable, sustained-release implant that releases dexamethasone for up to 6 months. We evaluated the efficacy and safety of DEX implant in the treatment of macular edema secondary to retinal vein occlusion (RVO) in treatment-naïve patients.
A multicenter, retrospective, open-label chart review study investigated the efficacy and safety of DEX implant treatment in 289 patients with macular edema secondary to branch or central RVO (BRVO, CRVO) who received ≥2 treatments with DEX implant in the study eye. Concomitant adjunctive RVO treatments were permitted. Data collected from the time of the first implant (baseline) to 3-6 months after the last implant included best-corrected visual acuity (BCVA) and central retinal thickness measured with optical coherence tomography. In this subgroup analysis, we evaluated outcomes in patients who had received no previous treatment for RVO complications.
Thirty-nine patients were treatment-naïve at the time of their first DEX implant (18 BRVO, 21 CRVO). Before the initial DEX implant, the mean duration of macular edema in treatment-naïve patients was 4.9 months, mean central retinal thickness was 550 μm, and mean Early Treatment Diabetic Retinopathy Study BCVA was 8.5 lines (20/125 Snellen). Treatment-naïve patients received a mean of 2.9 implants, either as monotherapy (n = 12) or with adjunctive RVO treatments (n = 27). The mean interval between implants was 177 days. After the first through sixth implants, mean changes from baseline BCVA ranged from +3.0 - +8.0 lines, and mean decreases from baseline central retinal thickness ranged from 241-459 μm. BCVA improved in both BRVO and CRVO and in both phakic and pseudophakic eyes. Overall, 83.8 % of treatment-naïve patients gained ≥2 lines in BCVA, 70.3 % gained ≥3 lines in BCVA, and 56.4 % achieved central retinal thickness ≤250 μm. The most common adverse event was increased intraocular pressure. Fifteen treatment-naïve patients had intraocular pressure ≥25 mm Hg; none required laser or incisional glaucoma surgery.
Treatment with 2 or more DEX implants had a favorable safety profile and improved visual acuity and anatomic outcomes when used, either alone or with adjunctive RVO therapy, as initial treatment for RVO-associated macular edema.
ClinicalTrials.gov NCT01411696 , registered on August 5, 2011.
地塞米松玻璃体内植入物（DEX植入物）是一种可生物降解的缓释植入物，可释放地塞米松长达6个月。我们评估了DEX植入物在初治患者中治疗视网膜静脉阻塞（RVO）继发黄斑水肿的疗效和安全性。
一项多中心、回顾性、开放标签的图表审查研究，调查了289例继发于分支或中央RVO（BRVO、CRVO）的黄斑水肿患者在研究眼中接受≥2次DEX植入物治疗的疗效和安全性。允许同时进行辅助性RVO治疗。从首次植入（基线）到最后一次植入后3至6个月收集的数据包括最佳矫正视力（BCVA）和用光学相干断层扫描测量的中央视网膜厚度。在该亚组分析中，我们评估了既往未接受过RVO并发症治疗的患者的结局。
39例患者在首次植入DEX时为初治患者（18例BRVO，21例CRVO）。在首次植入DEX之前，初治患者黄斑水肿的平均持续时间为4.9个月，平均中央视网膜厚度为550μm，平均早期糖尿病视网膜病变研究BCVA为8.5行（20/125 Snellen）。初治患者平均接受2.9次植入，可作为单一疗法（n = 12）或与辅助性RVO治疗联合使用（n = 27）。植入物之间的平均间隔为177天。在首次至第六次植入后，BCVA相对于基线的平均变化范围为+3.0 - +8.0行，中央视网膜厚度相对于基线的平均减少范围为241 - 459μm。BRVO和CRVO以及有晶状体和人工晶状体眼的BCVA均有所改善。总体而言，83.8%的初治患者BCVA提高≥2行，70.3%提高≥3行，56.4%的患者中央视网膜厚度≤250μm。最常见的不良事件是眼压升高。15例初治患者眼压≥25 mmHg；无人需要激光或切开性青光眼手术。
使用2次或更多次DEX植入物进行治疗具有良好的安全性，并且在单独使用或与辅助性RVO治疗联合使用作为RVO相关黄斑水肿的初始治疗时，可改善视力和解剖学结局。
ClinicalTrials.gov NCT01411696，于2011年8月5日注册。
