Avila M P, Farah M E, Santos A, Duprat J P, Woodward B W, Nau J
Centro Brasileiro de Cirurgia de Olhos, CEP 74210-010 Goiânia-Goiás, Brazil.
Br J Ophthalmol. 2009 Mar;93(3):305-9. doi: 10.1136/bjo.2008.145912. Epub 2008 Nov 19.
BACKGROUND/AIMS: This study evaluated the short-term safety and feasibility of epiretinal strontium-90 brachytherapy delivered concomitantly with intravitreal bevacizumab for the treatment of subfoveal CNV due to AMD for 12 months. A 3-year follow-up is planned.
In this prospective, non-randomised, multicentre study, 34 treatment-naïve patients with predominantly classic, minimally classic and occult subfoveal CNV lesions received a single treatment with 24 Gy beta radiation (strontium-90) and two injections of the anti-VEGF antibody bevacizumab. Adverse events were observed. BCVA was measured using standard ETDRS vision charts.
Twelve months after treatment, no radiation-associated adverse events were observed. In the intent-to-treat (ITT) population, 91% of patients lost <3 lines (15 ETDRS letters) of vision at 12 months, 68% improved or maintained their BCVA at 12 months, and 38% gained >/=3 lines. The mean change in BCVA observed at month 12 was a gain of 8.9 letters.
The safety and efficacy of intraocular, epiretinal brachytherapy delivered concomitantly with anti-VEGF therapy for the treatment of subfoveal CNV secondary to AMD were promising in this small study population. Long-term safety will be assessed for 3 years. This regimen is being evaluated in a large, multicentre, phase III study.
背景/目的：本研究评估了视网膜下锶-90近距离放射治疗联合玻璃体内注射贝伐单抗治疗年龄相关性黄斑变性（AMD）所致黄斑下脉络膜新生血管（CNV）12个月的短期安全性和可行性。计划进行3年随访。
在这项前瞻性、非随机、多中心研究中，34例初治的主要为典型、最小典型和隐匿性黄斑下CNV病变的患者接受了一次24 Gyβ射线（锶-90）治疗和两次抗血管内皮生长因子（VEGF）抗体贝伐单抗注射。观察不良事件。使用标准ETDRS视力表测量最佳矫正视力（BCVA）。
治疗12个月后，未观察到与放射相关的不良事件。在意向性治疗（ITT）人群中，91%的患者在12个月时视力下降<3行（15个ETDRS字母），68%的患者在12个月时BCVA改善或维持，38%的患者视力提高≥3行。12个月时观察到的BCVA平均变化为提高8.9个字母。
在这个小研究人群中，眼内视网膜下近距离放射治疗联合抗VEGF治疗AMD继发黄斑下CNV的安全性和有效性前景良好。将评估3年的长期安全性。该治疗方案正在一项大型多中心III期研究中进行评估。
