Clinical Ophthalmology (Nov 2024)

Transitioning from Aflibercept to Biosimilar Ranibizumab in Diabetic Macular Edema (DME): (The TRANSFORM-DME Trial) a Multicenter Observational Study

  • Chakraborty D,
  • Sinha TK,
  • Maiti A,
  • Boral SK,
  • Das A,
  • Mondal S,
  • Nandi K,
  • Bhattacharya R

Journal volume & issue
Vol. Volume 18
pp. 3449 – 3456

Abstract

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Debdulal Chakraborty,1 Tushar Kanti Sinha,1 Aniruddha Maiti,2 Subhendu Kumar Boral,1 Arnab Das,1 Soumen Mondal,1 Krishnendu Nandi,3 Ranabir Bhattacharya1 1Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India; 2Department of Vitreoretinal Services, Global Eye Hospitals, Kolkata, West Bengal, India; 3Department of Vitreoretinal Services, Netralayam Superspeciality Eye Care, Kolkata, West Bengal, IndiaCorrespondence: Debdulal Chakraborty, Department of Vitreo-Retinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India, Tel +91 33 6636 0000, Email [email protected]: To evaluate visual and anatomical outcomes following a switch from intravitreal Aflibercept (IVI AFL) (T1) to biosimilar Ranibizumab (B-RBZ) (T2) in patients with diabetic macular edema (DME).Methods: This was a multicenter observational study, analysing medical records of consecutive, treatment-naïve centre-involving DME patients having a baseline visual acuity (VA) of ≥ 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. DME patients, having received monthly loading doses of IVI AFL(T1) and responsive to it, who subsequently shifted to B-RBZ(T2) motivated by financial constraints rather than a lack of efficacy to IVI AFL were identified.Results: This study included 57 participants (mean age: 54.23 ± 6.91 years), with 80.7% male patients. VA improved during T1, from 61.4 ± 11.74 ETDRS letters at baseline to 72.7 ± 8.05 ETDRS letters (mean change: +11.2 letters, 95% CI: 9.1 to 13.4; p < 0.001). During T2, VA declined slightly over 12 months with a mean VA of 69.9 ± 3.78 ETDRS letters at the 12-month mark (+8.5 letters from baseline; p < 0.001). Mean central macular thickness (CMT) during T1 reduced from 411.9 ± 34.62 μm at baseline to 279.3 ± 9.96 μm (mean change: − 132.6 μm, 95% CI: − 142.2 to − 122.9 μm; p < 0.001). CMT remained stable over the 12-month follow-up period, with minimal fluctuations. Subretinal fluid (SRF) and intra retinal fluid (IRF) were present in 84.2% and 91.2% of eyes, respectively, decreasing to 5.3% and 7.0% at the time of switch (p < 0.001). In T2 phase, 22.8% and 21.1% exhibited SRF and IRF, respectively, at the end of the study.Conclusion: Transitioning to biosimilar Ranibizumab (Razumab) after initial treatment with aflibercept in patients with DME preserved visual and anatomical benefits over a 12-month period, with only minor variations in SRF and IRF. These results underscore the efficacy of biosimilar Ranibizumab as a cost-effective option for managing DME.Keywords: diabetic macular edema, anti VEGF, aflibercept, biosimilar ranibizumab

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