Stereotactic radiotherapy for neovascular age related macular degeneration: year 3 and 4 extended follow up results of a randomised, double masked, sham controlled, device trial (STAR).

Methods

Randomised, double masked, sham controlled, device trial involving preplanned recall from standard care.

随机、双盲、安慰剂对照的设备试验，涉及从标准护理中预先计划的召回。

30 NHS hospitals in the UK.

英国的30家国家医疗服务体系（NHS）医院。

411 participants aged at least 50 years with chronic, pretreated, active AMD.

411名年龄至少为50岁的参与者，他们患有慢性、已治疗的活动性年龄相关性黄斑变性（AMD）。

intervention

Participants received one-off 16 Gray SRT or sham SRT delivered using a robotically controlled device.

参与者接受了一次性使用机器人控制设备进行的16 Gy SRT或模拟SRT治疗。

After two years of monthly study visits, participants reverted to routine care, with anti-VEGF drug selection and dosing intervals based on local practice, but with masking maintained, and repeat data collection at years 3 and 4 study visits.

在为期两年的每月研究访问后，参与者恢复常规护理，抗VEGF药物的选择和给药间隔基于当地实践，但保持了盲法，且在第3年和第4年的研究访问时重复收集数据。

Methods

The main efficacy outcome at year 4 was the number of anti-VEGF injections, tested for superiority (fewer injections).

第四年的主要疗效结果是抗血管内皮生长因子（anti-VEGF）注射次数，测试其优越性（较少的注射次数）。

The other main outcome was visual acuity, tested for non-inferiority (five letter margin).

另一个主要结果是视力，测试其非劣效性（五字母的边界）。

Safety outcomes included adverse events, serious adverse events, and microvascular abnormalities.

安全性结果包括不良事件、严重不良事件和微血管异常。

The same analyses were undertaken at years 2, 3, and 4.

在第2年、第3年和第4年进行了相同的分析。

A within trial costing analysis was undertaken for participants with four years' follow-up.

对随访四年的参与者进行了试验内成本分析。

Results

Of 411 participants (204 (58%) women), 274 were allocated to SRT and 137 to sham SRT.

在411名参与者中（204名（58%）为女性），274人被分配到SRT组，137人被分配到假SRT组。

The year 4 intention-to-treatefficacy analysis included 222 (81%) participants in the SRT group and 106 (77%) in the sham SRT group.

第4年的意向治疗效果分析包括了SRT组的222名（81%）参与者和安慰剂SRT组的106名（77%）参与者。

The SRT group received a mean of 19.1 (standard deviation 10.9) injections over four years versus 21.6 (11.3) with sham SRT, an adjusted decrease of 3.2 injections (95% confidence interval(CI) of difference -5.7 to -0.7).

SRT组在四年内平均接受了19.1（标准差10.9）次注射，而安慰剂SRT组为21.6（11.3）次，调整后的注射次数减少了3.2次（差异的95%置信区间为-5.7至-0.7）。

During years 3 and 4, the SRT group received a mean cumulative 8.4 injections versus 8.3 injections in the sham SRT group.

在第3年和第4年期间，SRT组接受了平均累积8.4次注射，而假SRT组接受了8.3次注射。

The final change in visual acuity in the SRT group was 8.3 letters worse than in the sham group (95% CI of difference -12.7 to -4.0).

SRT组的最终视力变化比假SRT组差8.3个字母（差异的95%置信区间为-12.7至-4.0）。

Adverse eventrates were similar between groups, but reading centre-detected microvascular abnormalities occurred in 126/218 SRT treated eyes (58%) and 16/102 (16%) sham SRT treated eyes.

两组之间的不良事件发生率相似，但读图中心检测到的微血管异常发生在218只接受SRT治疗的眼睛中有126只（58%），而在102只接受假SRT治疗的眼睛中有16只（16%）。

Conclusions

Although the overall reduction in intravitreal therapy was maintained to year 4, the inferior vision in SRT treated eyes effectively reversed the conclusions of the year 2 primary outcome analysis and no longer supports the use of SRT to treat neovascular AMD.

尽管在第4年时，玻璃体内治疗的总体减少仍然保持，但SRT治疗眼的视力下降有效地逆转了第2年主要结果分析的结论，不再支持使用SRT治疗新生血管性AMD。

Including standard care, masked, extended follow-up within a clinical trial may provide useful clinical insight.

在临床试验中，包括标准治疗在内的盲法延长随访可能提供有用的临床见解。

trial_registration

ClinicalTrials.gov NCT02243878.

ClinicalTrials.gov NCT02243878。