Effectiveness and safety of ranibizumab in patients with central retinal vein occlusion: results from the real-world, global, LUMINOUS study

Andrew Lotery,Xun Xu,Focke Ziemssen,Ramin Tadayoni,Marco Nardi,Andreas Clemens,Raman Tuli,On Behalf Of The Luminous™ Study Group ,Cornelia Dunger-Baldauf,Masahiko Shimura

doi:10.1038/s41433-021-01702-y

Abstract

ObjectiveTo evaluate the effectiveness, treatment patterns and long-term safety of ranibizumab 0.5 mg in treatment-naïve patients with central retinal vein occlusion (CRVO) in a real-world setting.MethodsLUMINOUS, a 5-year, global, prospective, multicentre, multi-indication, observational, open-label study, recruited treatment naïve or prior treated patients who were treated as per the local ranibizumab label. Here, we report the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure over year (Y) 1 and 5-year safety in treatment-naïve CRVO patients.ResultsAt baseline, the mean age of treatment-naïve CRVO patients (n = 327) was 68.9 years, with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) letters with 1, 2–3, 4–5, 6–8 and >8 ranibizumab injections, respectively. Mean (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 11.3%/8.6% and 1.2%/6.7%, respectively.ConclusionsThese results demonstrate the effectiveness of ranibizumab in treatment-naïve CRVO patients at Y1 with clinically meaningful VA gains and no new safety findings over five years. These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes.

Highlights

The global prevalence of central retinal vein occlusion (CRVO) is 0.08% in patients aged ≥ 30 years and does not significantly vary with regard to race or gender [1,2,3]
Ranibizumab treatment resulted in improved visual acuity (VA) outcomes at the end of 1 year in these patients
Across all enroling countries we identified a similar pattern, i.e. that patients with a low baseline VA or those receiving higher numbers of ranibizumab injections or those treated with an adequate loading dose achieved better VA outcomes

Summary

Introduction

The global prevalence of central retinal vein occlusion (CRVO) is 0.08% in patients aged ≥ 30 years and does not significantly vary with regard to race or gender [1,2,3]. Ranibizumab (Lucentis®; Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA) was the first anti-VEGF agent to be approved for the treatment of patients with visual impairment due to macular oedema secondary to retinal vein occlusion (branch and central) and is currently approved in many countries globally for this indication [9,10,11]. The LUMINOUS (NCT01318941) study is, to our knowledge, the largest, prospective, observational, global trial in the field of medical retina designed to evaluate the long-term effectiveness, safety and treatment patterns associated with ranibizumab 0.5 mg in routine clinical practice across five approved indications: (i) neovascular age-related macular degeneration, (ii) diabetic macular oedema, (iii) branch retinal vein occlusion, (iv) CRVO and (v) myopic choroidal neovascularisation. The effectiveness of ranibizumab at one year and safety over five years for treatment-naïve patients with CRVO enroled in this study are reported here

Methods

Results

Conclusion