M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India.
Consultant Vitreoretinal Surgeon, Future Vision Eye Care and Research Centre, Mumbai, India.
Indian J Ophthalmol. 2023 Feb;71(2):411-415. doi: 10.4103/ijo.IJO_973_22.
To evaluate the efficacy of a biosimilar ranibizumab (Razumab) on outcomes of retinopathy of prematurity (ROP) for the first time.
This retrospective study included infants presenting with stage 3+ ROP either in zone 1 or zone 2 posterior or aggressive posterior ROP (APROP). All eligible infants received intravitreal razumab (0.25 mg/0.025 ml) monotherapy. Follow-up was continued monthly till complete retinal vascularization was achieved while retreatment with razumab was given when recurrent neovascularization was noted. In case of no recurrence but incomplete vascularization, laser photocoagulation was done to the residual avascular retina.
We included 118 eyes of 59 infants with a median gestational age of 30 weeks and median birth weight of 1250 grams. At presentation, APROP was found in 28 eyes (24%) of 14 babies while stage 3 disease was seen in zone 1 in another 28 eyes (24%) and the remaining 62 eyes (52%) had stage 3 ROP in zone 2 posterior region. Complete resolution of ROP along with complete vascularization was seen in 22 eyes (19%) at a median of 55 days (IQR = 31-56 days) and 42 eyes (35%) showed a recurrent neovascularization at a median of 51 days post razumab (IQR = 42-55 days). The cumulative incidence of recurrence of neovascularization (21%, 95% CI = 14%-29%) peaked at seven weeks and was significantly higher in eyes with APROP (43%, 95% CI = 27%-63%) compared to eyes without APROP (13.4%, 95%CI, 8%-22%) (P < 0.001).
Razumab appears to be safe and effective in treating ROP, with about a third requiring reinjection at seven weeks after the first dose.
首次评估生物类似物雷珠单抗（Razumab）治疗早产儿视网膜病变（ROP）结局的疗效。
本回顾性研究纳入了患有 1 区或 2 区后部或侵袭性后部 ROP（APROP）的 3+期 ROP 的婴儿。所有符合条件的婴儿均接受玻璃体内雷珠单抗（0.25mg/0.025ml）单药治疗。在完成视网膜血管化之前，每月进行一次随访，当出现新生血管复发时，给予雷珠单抗再次治疗。如果没有复发但血管化不完全，则对残留无血管视网膜进行激光光凝。
我们纳入了 59 名婴儿的 118 只眼，中位胎龄为 30 周，中位出生体重为 1250 克。在就诊时，14 名婴儿中有 28 只眼（24%）患有 APROP，28 只眼（24%）在 1 区有 3 期疾病，其余 62 只眼（52%）在 2 区后部有 3 期 ROP。22 只眼（19%）在中位 55 天（IQR=31-56 天）完全缓解 ROP 并完全血管化，42 只眼（35%）在雷珠单抗治疗后中位 51 天（IQR=42-55 天）出现新生血管复发。新生血管再发的累积发生率（21%，95%CI=14%-29%）在 7 周时达到峰值，且在患有 APROP 的眼中明显更高（43%，95%CI=27%-63%），而在无 APROP 的眼中则较低（13.4%，95%CI，8%-22%）（P<0.001）。
雷珠单抗治疗 ROP 似乎安全有效，约三分之一的患者在首次注射后 7 周需要再次注射。
