Innovator ranibizumab ComparEd to Biosimilar ranibizumab in combination with Expansile gas in submaculaR HemorrhaGe: the ICEBERG study.

IF 1.7 4区医学 Q3 OPHTHALMOLOGY BMC Ophthalmology Pub Date : 2025-01-23 DOI:10.1186/s12886-025-03846-x

Debdulal Chakraborty, Tushar Kanti Sinha, Soumen Mondal, Subhendu Boral, Arnab Das, Saptorshi Majumbar, Angshuman Mukherjee, Ranabir Bhattacharya, Sumit Randhir Singh

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Abstract

Purpose: To compare the anatomical and visual outcomes in eyes with submacular hemorrhage (SMH) treated with a combination of ranibizumab (RBZ) either innovator or biosimilar (Razumab) and intravitreal perfluoropropane gas (C₃F₈).

Methods: Treatment naïve neovascular age related macular degeneration (n-AMD) patients with SMH were retrospectively analyzed. Patients received either innovator or biosimilar RBZ (3 loading doses followed by pro re nata regimen) and single injection of intravitreal C₃F₈. Optical coherence tomography (OCT) was performed at baseline, 1, 3 and 6 months. Changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) were assessed at 6 months. P value ≤ 0.05 was considered statistically significant.

Results: A total of 67 eyes (35 and 32 eyes in innovator and biosimilar group respectively) were analyzed. BCVA improved from 1.15 ± 0.19 to 0.51 ± 0.23 logarithm of minimum angle of resolution (logMAR) in innovator RBZ group (p < 0.001) and from 1.17 ± 0.15 to 0.53 ± 0.20 logMAR in biosimilar RBZ group (p < 0.001). Similarly, mean CMT showed significant reduction in both groups at 6 months (innovator RBZ: 609.5 ± 50.1 μm to 254.3 ± 20.3 μm, p < 0.001; biosimilar RBZ: 602.3 ± 58.9 μm to 251.8 ± 22.3 μm, p < 0.001). Intergroup comparisons between innovator and biosimilar RBZ showed no differences in either BCVA or CMT at all time points (all p values > 0.05). Mean number of intravitreal injections was marginally higher in innovator group compared to biosimilar RBZ (4.37 ± 0.49 vs. 4.22 ± 0.42; p = 0.18).

Conclusion: Biosimilar RBZ may act as a viable alternative to innovator RBZ to treat SMH with comparable anatomical and visual outcomes at 6 months.

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创新雷尼单抗与生物仿制药雷尼单抗联合膨胀气体治疗黄斑下出血的冰山研究

目的：比较雷尼单抗（RBZ）创新药或生物仿制药（Razumab）和玻璃体内全氟丙烷气体（C3F8）联合治疗黄斑下出血（SMH）的解剖和视力结果。方法：回顾性分析naïve新生血管年龄相关性黄斑变性（n-AMD）合并SMH患者的治疗情况。患者接受创新药物RBZ或生物仿制药RBZ（3次加载剂量，然后再进行自然治疗方案）和单次玻璃体内注射C3F8。分别在基线、1、3和6个月进行光学相干断层扫描（OCT）。6个月时评估最佳矫正视力（BCVA）和中央黄斑厚度（CMT）的变化。P值≤0.05认为有统计学意义。结果：共分析67只眼（创新组35只，生物仿制药组32只）。创新RBZ组BCVA最小分辨角（logMAR）的对数由1.15±0.19提高至0.51±0.23 （p < 0.05）。创新组的平均玻璃体内注射次数略高于生物仿制药RBZ(4.37±0.49比4.22±0.42；p = 0.18)。结论：生物仿制药RBZ可能作为创新RBZ治疗SMH的可行替代方案，在6个月时具有相似的解剖和视觉效果。

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来源期刊

BMC Ophthalmology OPHTHALMOLOGY-

CiteScore

3.40

自引率

5.00%

发文量

441

审稿时长

6-12 weeks

期刊介绍： BMC Ophthalmology is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of eye disorders, as well as related molecular genetics, pathophysiology, and epidemiology.