Журнал клинической и экспериментальной офтальмологии
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ISSN: 2155-9570
ISSN: 2155-9570
Shashikant Sharma, RE-ENACT 2 Study Investigators Group, Mujtaba A Khan and Alok Chaturvedi
Objective: The effectiveness of RazumabTM (world’s first biosimilar ranibizumab) in macular disorders was
established in the RE-ENACT study. The current RE-ENACT 2 study was conducted to evaluate the effectiveness of
biosimilar ranibizumab in macular disorders for a longer-term.
Methods: RE-ENACT 2 was a multicenter, retrospective data collection study. Data were collected from the
medical records of adult patients who received biosimilar ranibizumab injections between July 2015 and February
2019 at multiple centers (17 centers) across India. The study comprised both the previously treated and treatment
naive patients. Data were analyzed for improvements in: best corrected visual acuity (BCVA), central subfield
thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF), subretinal
fluid (SRF) from baseline at Weeks 4, 8, 12, 16, 20, 24, 30, 36 and 48.
Results: A total of 341 patients were included in this study. Majority of the patients were also suffering from
hypertension (58.1%) and diabetes (15.8%). The disease indications comprised wet age-related macular
degeneration (wet AMD, 30.2%, n=103), retinal vein occlusion (RVO, 29.6%, n=101), diabetic macular edema
(DME, 30.2%, n=103) and myopic choroidal neovascularization (mCNV, 10%, n=34). Majority of the patients were
men (60.1%) and were treatment naïve (73.6%); majority (59.2%) of the patients had received 3 (range 1-5)
biosimilar ranibizumab injections. From baseline to all timepoints, significant improvements (P<0.001) were
observed for BCVA (baseline: 0.89 ± 0.6; Week 48: 0.43 ± 0.3) and CSFT (baseline: 467.09 ± 159.6; Week 48:
296.56 ± 49.7). Minimal changes in IOP, though not significant, were observed (baseline: 14.92 ± 3.4; Week 48:
13.89 ± 2.2; P=0.4307). A decrease in proportions of patients having IRF and SRF was also observed. There were
no new safety concerns reported.
Conclusion: The RE-ENACT 2 study further strengthens the data of biosimilar ranibizumab with improvements in
visual acuity and disease outcomes observed for a longer follow-up duration up to 48 weeks in patients with wet
age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal
neovascularization without any new safety issues.