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首页> 外文期刊>Retina >Three-year safety and visual acuity results of epimacular 90 strontium/90 yttrium brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration.
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Three-year safety and visual acuity results of epimacular 90 strontium/90 yttrium brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration.

机译：黄斑90锶/ 90钇近距离放疗联合贝伐单抗治疗因年龄相关性黄斑变性继发的黄斑下脉络膜新生血管的三年安全性和视敏度结果。

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PURPOSE: To evaluate the long-term safety and visual acuity outcomes associated with epimacular strontium 90 brachytherapy combined with intravitreal bevacizumab for the treatment of subfoveal choroidal neovascularization because of age-related macular degeneration. METHODS: Thirty-four treatment-naive patients with predominantly classic, minimally classic, and occult subfoveal choroidal neovascularization lesions participated in this prospective, 2-year, nonrandomized multicenter study. Subjects from 1 center (n = 19) were reconsented and followed-up for 3 years. Each subject received a single 24-Gy beta irradiation treatment via an intraocular delivery device and 2 planned injections of bevacizumab at treatment and 1 month later. Additional bevacizumab therapy was permitted based on prespecified retreatment criteria. Adverse events were observed, and best-corrected visual acuity was measured using Early Treatment Diabetic Retinopathy Study vision charts. Subjects were evaluated every 3 months during the first year of follow-up and every 6 months during Years 2 and 3 of follow-up. RESULTS: All 34 subjects were followed-up for 24 months and 19 were followed-up through 36 months. With up to 24 months of follow-up, 12 of 24 phakic patients (50%) exhibited >/= 2 grades of progression in Lens Opacification Classification System (LOCS) II lens classification; 5 eyes underwent cataract extraction before the Month 36 visit. There was 1 case of nonproliferative retinopathy identified at 36 months of follow-up that did not have an adverse effect on visual acuity, was stable at 43 months of follow-up, and was isolated to the parafoveal region. Mean best-corrected visual acuity demonstrated an average gain of +15.0 and -4.9 letters at 12 months and 24 months, respectively; the drop in mean gain at Month 24 was largely attributable to cataract formation. At 36 months (n = 19), the mean best-corrected visual acuity was +3.9, 90% (17 of 19) of eyes had lost <15 letters from baseline, 53% (10 of 19) had gained >/= 1 letter, and 21% (4 of 19) had gained >/= 15 letters. Through 36 months, 11 eyes required additional bevacizumab retreatment therapy and received a mean of 3.0 injections (range, 2-7 injections). CONCLUSION: Epimacular brachytherapy shows promise as a therapeutic option for subfoveal neovascular age-related macular degeneration. The procedure was safe and well tolerated, with a reasonable risk-benefit profile that warrants further study in larger subject populations. The most common adverse event was cataract progression/formation. Surgical complications are similar to those expected from standard vitrectomy trials. This novel device is currently being evaluated in two prospective, randomized, controlled trials in treatment-naive subjects (CABERNET) and in subjects already treated with anti-vascular endothelial growth factor therapy (MERLOT).
机译：目的：评价与年龄相关的黄斑变性所引起的黄斑锶90近距离放疗联合玻璃体内贝伐单抗联合治疗小凹下脉络膜新生血管的长期安全性和视敏度。方法：34例初治，主要为经典，极少经典和隐匿性小凹下脉络膜新生血管病变的患者参加了这项为期2年的非随机多中心研究。接受了来自1个中心（n = 19）的受试者的随访3年。每位受试者通过眼内递送装置接受一次24-Gyβ放射治疗，并在治疗时和1个月后进行2次计划的贝伐单抗注射。根据预先指定的再治疗标准，允许进行其他贝伐单抗治疗。观察到不良事件，并使用“早期治疗性糖尿病视网膜病变研究”视力表测量最佳矫正视力。在随访的第一年中，每3个月对受试者进行一次评估，在随访的2年和3年中，每6个月对受试者进行一次评估。结果：全部34名受试者均接受了24个月的随访，其中19名随访了36个月。经过长达24个月的随访，在24例晶状体屈光不正患者中，有12例（50％）的晶状体混浊分类系统（LOCS）II表现为> / = 2级。在第36个月访视之前，对5只眼睛进行了白内障摘除。在随访的36个月中发现1例非增生性视网膜病变，对视敏度无不良影响，在随访的43个月中稳定，并分离到了中央凹旁区域。平均最佳矫正视力在12个月和24个月时分别显示了+15.0和-4.9个字母的平均增益;第24个月的平均收益下降主要归因于白内障的形成。在36个月（n = 19）时，平均最佳矫正视力为+3.9，有90％（19中的17）的眼睛丢失了少于基线的15个字母，53％（19中的10）的眼睛获得了> / = 1字母，其中21％（19个中的4个）获得了> / = 15个字母。在36个月内，有11只眼睛需要额外的贝伐单抗再治疗，平均接受了3.0次注射（范围为2-7次注射）。结论：黄斑近距离放射治疗有望成为小凹下新血管性年龄相关性黄斑变性的治疗选择。该程序安全且耐受性良好，具有合理的风险收益特征，因此有必要在更大的受试者人群中进行进一步研究。最常见的不良事件是白内障进展/形成。手术并发症与标准玻璃体切除术试验所预期的相似。目前，该新装置正在两项未经治疗的受试者（CABERNET）和已接受抗血管内皮生长因子疗法（MERLOT）治疗的受试者的前瞻性，随机，对照试验中进行评估。

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