Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study

PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.


Objective: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naïve patients with branch retinal vein occlusion (BRVO) enrolled in the LUMINOUS™ study.

Study design: A 5-year, global, prospective, multicenter, observational, open-label study conducted in a clinical practice (real-world) setting at outpatient ophthalmology clinics that recruited 30,138 consenting adult patients from all approved indications for ranibizumab across 42 countries. Patients with BRVO were treated according to the local ranibizumab label of the participating countries. Mean change in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters from baseline to Year 1, treatment exposure during Year 1, and adverse events (AEs) over 5 years were assessed.

Results: Of the 1366 recruited BRVO patients, 405 were treatment-naïve at baseline with a mean (standard deviation [SD]) age of 67.9 (12.5) years, 57.5% were female, and 71.8% were White. At Year 1 (n = 189), the mean (SD) VA gain was 11.9 (17.66) letters from a baseline of 49.2 (±20.32) letters with a mean (SD) of 5.0 (2.34) injections. VA gains were higher in patients (n = 83) who received 6-9 injections (13.6 [20.16] letters) than in those who received 2-5 injections (n = 92, 11.7 [15.43] letters), or 1 injection (n = 14, 3.6 [13.72] letters). Patients with baseline VA <23 letters had numerically highest VA gains (n = 20, 31.1 [24.48] letters). Over 5 years, the rate of ocular/non-ocular AEs was 7.4%/9.1% and serious AEs was 0.3%/4.4% in treatment-naïve BRVO patients (n = 405).

Conclusions: One year results from the LUMINOUS real-world study showed a clinically meaningful VA improvement with ranibizumab in treatment-naïve patients with BRVO; numerically higher VA gains were achieved in patients who received more injections and those with poor baseline VA. No new safety signals were observed.

Trial registration: NCT01318941.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / therapeutic use*
  • Conjunctivitis / etiology
  • Female
  • Humans
  • Intraocular Pressure
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab / adverse effects
  • Ranibizumab / therapeutic use*
  • Retinal Vein Occlusion / drug therapy*
  • Treatment Outcome
  • Visual Acuity


  • Angiogenesis Inhibitors
  • Ranibizumab

Associated data


Grant support

This study was funded and sponsored by Novartis Pharma AG, Basel, Switzerland and is registered with (NCT01318941). The sponsor had a role in the study design, conducting the study, data collection, data analysis, data interpretation and manuscript preparation. Additionally, Novartis Pharma AG was responsible for the conduct of the study and oversight of the collection and management of data. The funder also provided support in the form of salaries for authors [A.C and C.D-B].