Zhao Miao, Zhang Ce, Chen Xi-Mei, Teng Yan, Shi Tian-Wei, Liu Fei
Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.
Drug Clinical Trials Institution, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.
Int J Ophthalmol. 2020 Nov 18;13(11):1765-1772. doi: 10.18240/ijo.2020.11.13. eCollection 2020.
To compare the safety and efficacy of the intravitreal injection of conbercept (IVC) and triamcinolone acetonide (IVTA) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO).
A prospective, randomized clinical study. Patients with ME secondary to BRVO were randomly assigned to either IVC group or IVTA group at a ratio of 2:1 and a 12-month follow-up was performed. The efficacy outcome measures included the mean changes and differences in best corrected visual acuity (BCVA) and the central retinal thickness (CRT). The safety profiles and the mean retreatment intervals were also compared.
There was no statistically significant difference of baseline between the two groups (IVC group, =36; IVTA group, =17). At 12mo, the BCVA letters improved by 27.31±18.36 in the IVC group, and 13.53±11.37 in the IVTA group (=0.0004). CRT reduction was 253.33±163.69 and 150.24±134.32 µm, respectively (=0.0034). The mean BCVA in the IVC group was superior to that of the IVTA group for months 6-12 (<0.01). The mean CRT at 9 and 12mo were thinner in the IVC group compared to the IVTA group (<0.01). The mean retreatment interval in the IVC group was longer than that in the IVTA group (97.40±36.27d 68.71±36.38d, =0.0030). One eye in the IVC group and seven eyes in the IVTA group developed elevated intraocular pressure (IOP; =0.0012). The proportion of eyes with cataract new-onset or progression were 19.44% in the IVC group and 64.71% in the IVTA group (=0.0012).
IVC could maintain or improve BCVA and reduce CRT for a longer time and have longer retreatment interval than IVTA. In addition, patients treated with IVTA are more susceptible to IOP elevation and cataract progression.
比较玻璃体内注射康柏西普（IVC）和曲安奈德（IVTA）治疗视网膜分支静脉阻塞（BRVO）继发黄斑水肿（ME）的安全性和有效性。
一项前瞻性随机临床研究。将BRVO继发ME的患者按2:1的比例随机分为IVC组或IVTA组，并进行为期12个月的随访。疗效指标包括最佳矫正视力（BCVA）和视网膜中央厚度（CRT）的平均变化及差异。还比较了安全性和平均再次治疗间隔时间。
两组基线无统计学显著差异（IVC组，n = 36；IVTA组，n = 17）。12个月时，IVC组BCVA字母数提高了27.31±18.36，IVTA组提高了13.53±11.37（P = 0.0004）。CRT降低分别为253.33±163.69和150.24±134.32 µm（P = 0.0034）。IVC组6至12个月时的平均BCVA优于IVTA组（P < 0.01）。IVC组9个月和12个月时的平均CRT比IVTA组更薄（P < 0.01）。IVC组的平均再次治疗间隔时间长于IVTA组（97.40±36.27天对68.71±36.38天，P = 0.0030）。IVC组有1只眼，IVTA组有7只眼发生眼压（IOP）升高（P = 0.0012）。IVC组新发或进展性白内障的眼比例为19.44%，IVTA组为64.71%（P = 0.0012）。
与IVTA相比，IVC能在更长时间内维持或改善BCVA并降低CRT，且再次治疗间隔时间更长。此外，接受IVTA治疗的患者更易发生IOP升高和白内障进展。
