A real-world experience with ranibizumab 0.5 mg initial intensive treatment for diabetic macular edema: 24-week outcomes of the RISING-K study

Abstract

Objective To evaluate the efficacy of initial intensive ranibizumab 0.5 mg treatment in Korean patients with diabetic macular edema (DME). Methods This was a multicenter, observational, retrospective study including patients with DME who received an initial intensive treatment, operationally defined as ≥3 ranibizumab 0.5 mg injections within 4 months (including the first dose). Primary outcome was mean change in best-corrected visual acuity (BCVA) at Week 24. Secondary outcomes were mean change in central subfield thickness (CST), intraretinal (IRF) and subretinal fluid (SRF), and diabetic retinopathy severity score (DRSS). Subgroup analyses evaluated these endpoints according to patients with/without prior anti-vascular endothelial growth factor (VEGF) treatment and by fluid compartment. Results Of total 83 patients (mean age: 63.4 years), 15 (18.1 %) received prior anti-VEGFs. At Week 24, mean BCVA gain from baseline was 5.1 ± 9.3 letters ( p < 0.001), 52.5 % and 13.8 % patients had ≥5 and ≥15 letters gain, respectively. Mean CST reduction from baseline was significant (−99.8 ± 122.1 μm; p < 0.001). DRSS improved in 19.2 % patients. BCVA gain showed higher tendency in eyes with prior anti-VEGF exposure (7.1 vs 4.7 letters; p = 0.0873), whereas CST reduction tended to be greater in treatment-naïve eyes (−106.7 vs −68.3 μm; p = 0.3377. All patients had IRF at baseline which disappeared in 29 % patients after 24 weeks resulting in BCVA improvement. At baseline, 23 % patients had SRF, of which 13 % resolved by Week 24. Patients without SRF at baseline had greater BCVA improvement, while patients with SRF at baseline had greater mean CST reduction. Conclusion Initial intensive treatment with ranibizumab 0.5 mg was effective in both treatment-naïve and prior-treated patients with DME. Functional outcomes varied by prior anti-VEGF treatment and fluid compartment.