Charlotte Eye, Ear, Nose & Throat Associates, Charlotte, North Carolina.
Jaeb Center for Health Research, Tampa, Florida.
JAMA. 2020 Dec 15;324(23):2383-2395. doi: 10.1001/jama.2020.23027.
Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.
To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020.
Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria.
The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years.
Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept.
Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation.
ClinicalTrials.gov Identifier: NCT02858076.
增生性糖尿病视网膜病变引起的玻璃体积血可导致视力丧失。最佳治疗方法尚不清楚。
比较玻璃体积血患者初始玻璃体腔内注射阿柏西普与玻璃体切割联合全视网膜光凝治疗增生性糖尿病视网膜病变的效果。
设计、地点和参与者：在美国和加拿大的 39 个 DRCR 视网膜网络站点进行的随机临床试验，包括 205 名因增生性糖尿病视网膜病变引起的玻璃体积血导致视力丧失的成年人，他们于 2016 年 11 月至 2017 年 12 月期间入组。最后一次随访于 2020 年 1 月完成。
将（每位参与者）1 只眼随机分配到阿柏西普组（100 只眼）或玻璃体切割联合全视网膜光凝组（105 只眼）。最初接受 4 次每月注射的阿柏西普组参与者。根据方案标准，两组都可以在随访期间接受阿柏西普或玻璃体切割。
24 周（曲线下面积）时平均视力字母评分（范围，0-100；分数越高表示视力越好）为主要结局；该研究的检测效能为 8 个字母。次要结局包括治疗后 4 周和 2 年的平均视力。
在 205 名（205 只眼）随机分组的参与者中（平均年龄[标准差]，57[11]岁；115[56%]为男性；平均视力字母评分，34.5[Snellen 等价物，20/200]），95%（195/205）完成了 24 周的随访，90%（177/196，不包括 9 例死亡）完成了 2 年的随访。阿柏西普组 24 周时的平均视力字母评分为 59.3（Snellen 等价物，20/63）（95%置信区间，54.9 至 63.7），玻璃体切割组为 63.0（Snellen 等价物，20/63）（95%置信区间，58.6 至 67.3）（调整后差异，-5.0[95%置信区间，-10.2 至 0.3]，P = .06）。在 23 项次要结局中，15 项无显著差异。阿柏西普组治疗后 4 周时的平均视力字母评分为 52.6（Snellen 等价物，20/100），玻璃体切割组为 62.3（Snellen 等价物，20/63）（调整后差异，-11.2[95%置信区间，-18.5 至 -3.9]，P = .003），2 年时为 73.7（Snellen 等价物，20/40）和 71.0（Snellen 等价物，20/40）（调整后差异，2.7[95%置信区间，-3.1 至 8.4]，P = .36）。在 2 年的随访中，33 只（33%）接受阿柏西普治疗的眼接受了玻璃体切割，34 只（32%）接受玻璃体切割治疗的眼随后接受了阿柏西普治疗。
在因增生性糖尿病视网膜病变引起的玻璃体积血的参与者中，与玻璃体切割联合全视网膜光凝相比，初始玻璃体腔内注射阿柏西普治疗 24 周后的主要结局（平均视力字母评分）无统计学显著差异。然而，考虑到 95%CI 的范围，该研究可能没有足够的效力来检测初始玻璃体切割联合全视网膜光凝治疗的临床重要获益。
ClinicalTrials.gov 标识符：NCT02858076。
