Ophthalmology. 1999 Dec;106(12):2239-47. doi: 10.1016/s0161-6420(99)90522-5.
To determine the efficacy of external beam radiation therapy on choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD).
Multicenter, parallel, randomized, double-masked clinical trial performed at nine ophthalmic and radiotherapeutic centers.
Two hundred five patients were randomly assigned either to treatment with 8 fractions of 2 Gy external beam irradiation (n = 101) or to control with 8 fractions of 0 Gy (sham treatment, n = 104). Both patients and ophthalmologists were masked with regard to applied treatment. Patients with subfoveal classic or occult CNV, visual acuity of 20/320 or greater on the Early Treatment Diabetic Retinopathy Study chart, lesion size of 6 disc areas or less, history of visual symptoms of 6 months or less, and absence of foveal hemorrhage were recruited.
In the treatment group, external beam irradiation with 8 fractions of 2 Gy was performed, whereas in the control group, sham treatment with 8 fractions of 0 Gy was applied.
Primary outcome measure was the difference in visual acuity between baseline and after 1 year of follow-up.
One hundred eighty-three patients (89.3%) completed the 1-year follow-up. The mean reduction in visual acuity was 3.5 +/- 4.7 lines in 88 patients of the 8- x 2-Gy treatment group and 3.7 +/- 3.8 lines in 95 patients of the 8- x 0-Gy control group. This difference was not statistically significant (P = 0.53, Mann-Whitney U test). At 1 year, 51.1% of treated patients and 52.6% of control subjects lost three or more lines (P = 0.88). Visual acuity in the presence of classic CNV dropped by 3.7 +/- 4.4 lines in 33 patients of the treatment group versus 4.3 +/- 3.9 lines in 36 patients of the control group (P = 0.47). Visual acuity in 114 patients with occult CNV dropped by 3.4 +/- 4.9 in the treatment group (55 patients) versus 3.4 +/- 3.8 lines in the control group (59 patients) (P = 0.80).
In this randomized study, radiation therapy at a dose of 16 Gy applied in 8 fractions of 2 Gy provided no benefit as a treatment for subfoveal CNV secondary to ARMD at 1 year.
确定外照射放疗对年龄相关性黄斑变性（ARMD）继发脉络膜新生血管（CNV）的疗效。
在9个眼科和放射治疗中心进行的多中心、平行、随机、双盲临床试验。
205例患者被随机分为两组，一组接受8次每次2 Gy的外照射放疗（n = 101），另一组接受8次每次0 Gy的对照治疗（假治疗，n = 104）。患者和眼科医生均对所接受的治疗不知情。招募了黄斑中心凹下典型或隐匿性CNV、早期糖尿病性视网膜病变研究视力表上视力为20/320或更好、病变大小为6个视盘面积或更小、视觉症状病史为6个月或更短且无黄斑出血的患者。
治疗组接受8次每次2 Gy的外照射放疗，而对照组接受8次每次0 Gy的假治疗。
主要观察指标是基线和随访1年后视力的差异。
183例患者（89.3%）完成了1年的随访。8次每次2 Gy治疗组的88例患者视力平均下降3.5±4.7行，8次每次0 Gy对照组的95例患者视力平均下降3.7±3.8行。这种差异无统计学意义（P = 0.53，曼-惠特尼U检验）。1年后，51.1%的治疗患者和52.6%的对照受试者视力下降3行或更多（P = 0.88）。治疗组33例典型CNV患者的视力下降3.7±4.4行，对照组36例患者的视力下降4.3±3.9行（P = 0.47）。114例隐匿性CNV患者中，治疗组（55例患者）视力下降3.4±4.9行，对照组（59例患者）视力下降3.4±3.8行（P = 0.80）。
在这项随机研究中，8次每次2 Gy给予16 Gy的放疗作为治疗ARMD继发黄斑中心凹下CNV 1年的治疗方法并无益处。
