Cincinnati Eye Institute and Department of Ophthalmology, University of Cincinnati, Cincinnati, Ohio.
Retina Associates of Kentucky, Lexington, Kentucky.
Retina. 2018 Apr;38(4):755-763. doi: 10.1097/IAE.0000000000001590.
To evaluate intravitreal aflibercept injection (IAI) in patients with presumed ocular histoplasmosis syndrome and choroidal neovascularization.
Open-label randomized Phase I/II study of IAI in patients with presumed ocular histoplasmosis syndrome-related choroidal neovascularization. Thirty-nine eyes from 39 patients were randomized in a 1:1 ratio to 2 groups. The Sustained Group eyes (n = 19) underwent monthly IAI for 3 months, then mandatory IAI every 2 months for 12 months (with an option for monthly PRN dosing, if needed). The PRN Group eyes (n = 20) received 1 IAI at randomization, then monthly PRN IAI for 12 months.
Thirty-nine eyes (19 eyes Sustained Group and 20 eyes PRN Group) were randomized. Average age of participants was 50 years (19-75), with 16 men and 23 women. Ten, 12, and 17 eyes demonstrated extrafoveal, juxtafoveal, and subfoveal choroidal neovascularization, respectively. All eyes in both groups received IAI at baseline, with the Sustained and PRN groups receiving on an average 7.5 (5-11) and 4.6 (1-10) injections, respectively, over the 12 months. At baseline, overall average visual acuity was 68 letters (13-87 letters) with Snellen equivalent of 20/42 (20/20-20/160). At 12-month follow-up, Sustained Group's average visual acuity was 84.9 letters (74-94) and Snellen equivalent was 20/21 (20/13-20/32), indicating an average improvement of 12 letters (6 letters loss to 36 letters gain) (P < 0.01). The PRN Group's 12-month average visual acuity was 80.9 letters (60-94) and Snellen equivalent was 20/26 (20/13-20/63), indicating an average gain of 19 letters (4-75) (P < 0.01). Mean baseline central subfield thickness (CST) was 374 μm and mean 1-year CST was 260 μm (P < 0.01) among all study participants. The Sustained Group's mean baseline CST was 383 μm and mean 12-month CST was 268 μm (P < 0.01). Mean baseline CST of the PRN Group was 360.8 μm, with the final mean CST of 260.5 μm (P < 0.01). No reported endophthalmitis, retinal tears, detachments, vitreous hemorrhage, nor adverse thrombotic events were reported.
Intravitreal aflibercept resulted in improved visual and anatomical outcomes with a favorable safety profile. PRN IAI dosing required less injections with similar visual and anatomical outcomes compared with sustained dosing.
评估玻璃体内注射阿柏西普（IAI）治疗疑似眼型组织胞浆菌病综合征和脉络膜新生血管化。
对疑似眼型组织胞浆菌病相关性脉络膜新生血管化患者进行玻璃体内注射阿柏西普的开放性、随机、I/II 期研究。39 名患者的 39 只眼被随机分为 1:1 比例的两组。持续组（n=19）在 3 个月内每月接受 IAI，然后每 2 个月强制性 IAI 治疗 12 个月（如果需要，可选择每月 PRN 剂量）。PRN 组（n=20）在随机分组时接受 1 次 IAI，然后每月 PRN IAI 治疗 12 个月。
39 只眼（持续组 19 只眼，PRN 组 20 只眼）被随机分组。参与者的平均年龄为 50 岁（19-75 岁），其中 16 名男性和 23 名女性。分别有 10、12 和 17 只眼显示出黄斑外、黄斑旁和黄斑下脉络膜新生血管化。两组所有眼均在基线时接受 IAI，持续组和 PRN 组分别平均接受 7.5（5-11）和 4.6（1-10）次注射，在 12 个月内完成。基线时，总体平均视力为 68 个字母（13-87 个字母），Snellen 等价物为 20/42（20/20-20/160）。在 12 个月的随访中，持续组的平均视力为 84.9 个字母（74-94），Snellen 等价物为 20/21（20/13-20/32），表明平均提高了 12 个字母（6 个字母损失到 36 个字母增益）（P<0.01）。PRN 组在 12 个月时的平均视力为 80.9 个字母（60-94），Snellen 等价物为 20/26（20/13-20/63），表明平均提高了 19 个字母（4-75）（P<0.01）。所有研究参与者的平均基线中央小凹下脉络膜厚度（CST）为 374 μm，平均 1 年 CST 为 260 μm（P<0.01）。持续组的平均基线 CST 为 383 μm，平均 12 个月 CST 为 268 μm（P<0.01）。PRN 组的平均基线 CST 为 360.8 μm，最终平均 CST 为 260.5 μm（P<0.01）。没有报告眼内炎、视网膜撕裂、脱离、玻璃体积血或不良血栓事件。
玻璃体内注射阿柏西普可改善视力和解剖学结果，且具有良好的安全性。与持续剂量相比，PRN IAI 剂量所需的注射次数更少，但视觉和解剖结果相似。
