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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引用次数: 0

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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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.