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

PURPOSE

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.