ABSTRACT
Purpose: This study investigates the efficacy of transitioning patients with neovascular age-related macular degeneration (nAMD) from aflibercept (T1) to biosimilar ranibizumab (T2), an approach not previously documented in literature. Methods: In this multicenter observational study, patients over 50 years of age with nAMD were shifted from intravitreal aflibercept (IVI AFL) to biosimilar ranibizumab (B-RBZ) due to financial constraints. This study employed standardized ophthalmological methods to assess visual acuity (VA), central macular thickness (CMT), and subretinal and intraretinal fluid. Statistical analyses included paired t-tests, Wilcoxon signed-rank tests, and linear regression. Results: A total of 29 eyes (12 males and 17 females) were analyzed. Mean age was 72.55 ±6.43 years. VA improved significantly during T1, with a mean increase from 55.0 ± 10.2 to 70.0 ± 8.5 ETDRS letters at the switch time point (p < 0.01), then a slight decrease to 62.3 ± 8.9 at 12 months (p < 0.05) was noted during T2. The mean CMT decreased notably from 400 ± 50 to 290 ± 45 µm at the switch. The final CMT at 12 months after switching to B-RBZ was 280 ± 40 µm (p < 0.01). There was a significant decrease in the retinal and intra retinal fluid during T1, followed by a gradual increase during T2. A significant correlation (p < 0.05) was noted between the presence of intraretinal fluid and increased injection frequency of B-RBZ. Conclusion: The switch from IVI AFL to IVI B-RBZ in patients with nAMD demonstrated efficacy in maintaining the VA and macular anatomy, with some challenges in fluid management.
ABSTRACT
Purpose: To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD). Methods: Retrospective observational study in nAMD patients, who were treated with IRM or BRM (3 loading doses followed by pro re nata (PRN). Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) along with safety analysis. Secondary outcomes measures were changes in the subretinal fluid (SRF) and intraretinal fluid (IRF). Results: Inclusion criteria were satisfied in 164 eyes (60.74%). A total of 87 eyes were treated with IRM, and 77 eyes received BRM. Baseline BCVA was 0.57±0.27 logMAR in IRM group and 0.61±0.25 in the BRM group. At 3, 6, 9, and 12 months BCVA was 0.27±0.22 (p<0.0001), 0.34±0.23 (p<0.0001), 0.39±0.25 (p<0.0001), and 12 months 0.41±0.23 (p<0.0001) in the IRM group and 0.24±0.16 (p<0.0001), 0.27±0.16 (p<0.0001), 0.34±0.17 (p<0.0001), 0.38±0.18 (p<0.0001) in the BRM group. Baseline CMT was 420.39±54.45 µm in IRM group and 407.82±53.07 µm in BRM group. At 3, 6, 9, and 12 months, CMT decreased to 258.28±20.4 µm (p<0.0001), 268.38±19.5 µm (p<0.0001), 269.51±32.41 µm (p<0.0001), and 278.28±16.56 µm (p<0.0001) in the IRM group and 258.84±17.47 µm (p<0.0001), 265.69±17.29 µm (p<0.0001), 273.64±23.13 µm (p<0.0001), and 283.09±19.66 µm (p<0.0001) in the BRM group. Similar improvements in IRF and SRF levels in the patients were noted in both groups. Required number of doses of IRM and BRM was similar over the 12 month period in both groups. A similar profile of adverse events was noted in both the groups. Conclusion: Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD.
ABSTRACT
INTRODUCTION: To compare the efficacy of innovator ranibizumab (iRBZ-Accentrix, Novartis, India) vs. biosimilar ranibizumab (bRBZ, Razumab-Intas, India) in eyes with diabetic macular edema (DME) in an Indian population. METHODS: Data of patients with DME who underwent at least three injections of iRBZ or bRBZ and had a minimum of 6 months follow-up were obtained from an electronic database. Choice of injection depended upon the patient. Pro re nata (PRN) protocol from baseline was used with reinjections advised if the central macular thickness (CMT) was at least 300 µm and best corrected visual acuity (BCVA) was 20/40 or worse. Primary outcome measure was comparison of change in BCVA at 6 months between iRBZ and bRBZ. RESULTS: We included 264 eyes in the iRBZ group and 69 eyes in bRBZ group, which were comparable for baseline characteristics. Mean BCVA improved from 0.64 ± 0.39 logMAR to 0.47 ± 0.31 logMAR (p < 0.001) in the iRBZ group and from 0.71 ± 0.42 logMAR to 0.50 ± 0.29 logMAR in the bRBZ group (p < 0.001) at 6 months. There were no differences in BCVA between the two groups (p > 0.05 for all time points). The CMT reduction in the iRBZ group (120 ± 196 µm) was comparable to that in the bRBZ group at 6 months (105 ± 187 µm) (p = 0.69). There was no difference in the mean number of injections taken (3.81 ± 1.2 in iRBZ vs. 3.55 ± 1.2 in bRBZ) (p > 0.05) between groups. Vision at baseline was the only factor associated with vision at last follow-up after adjusting for CMT at baseline, type of injection, and number of injections. CONCLUSIONS: Biosimilar RBZ is similar to innovator RBZ in improving vision and reducing CMT in eyes with DME in the short term.
