Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study

PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.


Purpose: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study.

Patients and methods: LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167).

Results: At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively.

Conclusions: Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.

Trial registration: ClinicalTrials.gov NCT01318941.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / administration & dosage
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Humans
  • Long Term Adverse Effects / epidemiology*
  • Macular Degeneration / drug therapy*
  • Male
  • Ranibizumab / administration & dosage
  • Ranibizumab / adverse effects
  • Ranibizumab / therapeutic use*
  • Visual Acuity


  • Angiogenesis Inhibitors
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT01318941

Grant support

FGH receives grants from Bayer, Centervue, Genentech/Roche, Heidelberg Engineering, Novartis, and Zeiss, and is a consultant for Acucela, Alcon, Bayer, Boehringer-Ingelheim, Galimedix, Genentech, Heidelberg Engineering, Lin-Bioscience, Khanghong, Oxurion, Novartis, Roche, and Zeiss. AMM is a consultant for Theà Laboratoire and receives travel and meeting grant from Allergan, Bayer Healthcare, Novartis Pharmaceutical, Theà Laboratoire. RT receives grants from Novartis, Roche and Apelis and is a member of Advisory boards in Novartis, Bayer. PY receives honoraria and non-financial support from Bayer and Novartis, honoraria from Alcon, Alimera Sciences, Allergan, Bausch and Lomb, Genentech, and Knight Therapeutics. SP is an employee of Novartis Pharma AG, Basel, Switzerland. RH Consultant for Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Roche; receives grants from Bayer Healthcare, Novartis Pharmaceuticals and Roche; receives lecture fees from Allergan, Roche, Bayer Healthcare, and Novartis Pharmaceuticals. Funding was provided by Novartis Pharma AG, Basel, Switzerland for the overall study design and medical writing and editorial assistance for this article. In conjunction with the LUMINOUS study group, Novartis Pharma AG, Basel, Switzerland, participated in the design of the study; analysis and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Additionally, Novartis Pharma AG was responsible for the conduct of the study and oversight of the collection and management of data. The study is registered with www.clinicaltrials.gov (NCT01318941).