Helmy Ahmed Magdy Raffat, Rashad Mohammad Ahmad, Gharieb Hesham Mohamed, Gomaa Wael Adel, Zaki Rania Gamal Eldin
Ophthalmology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Med Hypothesis Discov Innov Ophthalmol. 2023 Feb 3;11(4):144-150. doi: 10.51329/mehdiophthal1459. eCollection 2022 Winter.
Proliferative diabetic retinopathy (PDR) is a serious sight-threatening disease, and half of the patients with high-risk PDR can develop legal blindness within 5 years, if left untreated. This study was aimed at comparing panretinal photocoagulation (PRP) and intravitreal ranibizumab injections in terms of radial peripapillary capillary (RPC) density on optical coherence tomography angiography (OCTA) in patients with treatment-naive PDR.
This open-label, prospective, randomized clinical trial included 50 patients with treatment-naive PDR with optic disc neovascularization and randomized them into two groups: group 1, with patients undergoing two sessions of PRP 2 weeks apart, and group 2, with patients received three intravitreal ranibizumab injections (0.5 mg) 1 month apart for 3 consecutive months. Patients underwent a full ophthalmological examination, including best-corrected distance visual acuity (BCDVA) measurement in the logarithm of minimal angle of resolution (logMAR) notation and OCTA before intervention and monthly after the last laser session or the first intravitreal ranibizumab injection for 3 months of follow-up. Visual field (VF) was tested at the beginning and end of 3 months.
Forty-two (84%) eyes completed the 3-month follow-up, including 22 eyes in the PRP group (88%) and 20 (80%) eyes in the ranibizumab group. The two groups were comparable in terms of demographic characteristics, diabetes duration, baseline BCDVA, glycated hemoglobin level, OCTA parameters, VF indices, and intraocular pressure (all > 0.05). The RPC density change from baseline to the 3-month follow-up was significantly lower in the PRP group than in the ranibizumab group (mean difference in RPC density change: - 3.61%; 95% confidence interval: - 5.57% to - 1.60%; = 0.001). The median (interquartile range) logMAR change from baseline to the 3-month follow-up (0.0 [0.2]) was significantly higher in the PRP group than in the ranibizumab group (- 0.15 [0.3]; < 0.05). The median changes in central foveal thickness from baseline to the 3-month follow-up differed significantly between the two groups ( = 0.001).
In eyes with PDR and neovascularization of the disc RPC density on OCTA increased in the ranibizumab group and decreased in the PRP group. Visual acuity gain was higher in the ranibizumab group than in the PRP group. Future multicenter trials addressing our limitations are required to verify the findings of this study.
增殖性糖尿病视网膜病变(PDR)是一种严重的视力威胁性疾病,高危PDR患者中若不治疗,半数患者会在5年内发展为法定盲。本研究旨在比较全视网膜光凝(PRP)和玻璃体内注射雷珠单抗对初治PDR患者光学相干断层扫描血管造影(OCTA)上的放射状视乳头周围毛细血管(RPC)密度的影响。
这项开放标签、前瞻性、随机临床试验纳入了50例有视盘新生血管的初治PDR患者,并将他们随机分为两组:第1组患者每隔2周接受2次PRP治疗;第2组患者连续3个月每月接受1次玻璃体内注射雷珠单抗(0.5mg)。患者在干预前及最后一次激光治疗或首次玻璃体内注射雷珠单抗后每月进行一次全面眼科检查,包括以最小分辨角对数(logMAR)表示的最佳矫正远视力(BCDVA)测量和OCTA检查,随访3个月。在3个月开始和结束时进行视野(VF)检查。
42只眼(84%)完成了3个月的随访,其中PRP组22只眼(88%),雷珠单抗组20只眼(80%)。两组在人口统计学特征、糖尿病病程、基线BCDVA、糖化血红蛋白水平、OCTA参数、VF指数和眼压方面具有可比性(均P>0.05)。从基线到3个月随访时,PRP组RPC密度的变化显著低于雷珠单抗组(RPC密度变化的平均差异:-3.61%;95%置信区间:-5.57%至-1.60%;P=0.001)。从基线到3个月随访时,PRP组logMAR的中位数(四分位间距)变化(0.0[0.2])显著高于雷珠单抗组(-0.15[0.3];P<0.05)。两组从基线到3个月随访时中心凹厚度的中位数变化有显著差异(P=0.001)。
在患有PDR和视盘新生血管的眼中,雷珠单抗组OCTA上的RPC密度增加,PRP组则降低。雷珠单抗组的视力改善高于PRP组。未来需要进行多中心试验以解决我们研究的局限性,从而验证本研究结果。