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Observational Study
. 2020 Sep;40(9):1673-1685.
doi: 10.1097/IAE.0000000000002670.

RANIBIZUMAB TREATMENT IN TREATMENT-NAIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Results From LUMINOUS, a Global Real-World Study

Frank G Holz  1 , Marta S Figueroa  2 , Francesco Bandello  3 , Yit Yang  4   5 , Masahito Ohji  6 , Hong Dai  7 , Halina Wykrota  8 , Sanjay Sharma  9 , Cornelia Dunger-Baldauf  10 , Sue Lacey  11 , Wayne Macfadden  10 , Paul Mitchell  12 ; all the LUMINOUS study investigators
Affiliations
Observational Study

RANIBIZUMAB TREATMENT IN TREATMENT-NAIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Results From LUMINOUS, a Global Real-World Study

Frank G Holz et al. Retina. 2020 Sep.

Abstract

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

Methods: This 5-year, prospective, multicenter, observational study recruited 30,138 adult patients (treatment-naive or previously treated with ranibizumab or other ocular treatments) who were treated according to the local ranibizumab label.

Results: Six thousand two hundred and forty-one treatment-naive neovascular age-related macular degeneration patients were recruited. Baseline (BL) demographics were, mean (SD) age 75.0 (10.2) years, 54.9% females, and 66.5% Caucasian. The mean (SD) visual acuity (VA; letters) gain at 1 year was 3.1 (16.51) (n = 3,379; BLVA, 51.9 letters [Snellen: 20/92]) with a mean (SD) of 5.0 (2.7) injections and 8.8 (3.3) monitoring visits. Presented by injection frequencies <3 (n = 537), 3 to 6 (n = 1,924), and >6 (n = 918), visual acuity gains were 1.6 (14.93), 3.3 (16.57), and 3.7 (17.21) letters, respectively. Stratified by BLVA <23 (n = 382), 23 to <39 (n = 559), 39 to <60 (n = 929), 60 to <74 (n = 994), and ≥74 (n = 515), visual acuity change was 12.6 (20.63), 6.7 (17.88), 3.6 (16.41), 0.3 (13.83), and -3.0 (11.82) letters, respectively. The incidence of ocular/nonocular adverse events was 8.2%/12.8% and serious adverse events were 0.9%/7.4%, respectively.

Conclusion: These results demonstrate the effectiveness and safety of ranibizumab in treatment-naive neovascular age-related macular degeneration patients.

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Conflict of interest statement

F. G. Holz: Consultant—Acucela, Bayer, Boehringer-Ingelheim, Genentech, Heidelberg Engineering, LIN Bioscience, Novartis, Pixium, Roche, and Zeiss; Grants—Allergan, Carl Zeiss Meditec, Genentech, Heidelberg Engineering, Nightstar, Novartis, Optos, Pixium, and Roche; Lecture fees—Bayer, Genentech, Heidelberg Engineering, Novartis, Roche, and Zeiss. M. S. Figueroa: Consultant—Alcon, Allergan, Bayer, Novartis, Roche, and Zeiss. F. Bandello: Consultant—Allergan, Bayer, Boehringer-Ingelheim, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Sooft, Thrombogenics, and Zeiss; Board membership, expert testimony, and lecture fees—Allergan, Bayer, Boehringer-Ingelheim, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Sooft, Thrombogenics, and Zeiss; Y. Yang: Research grants—Alcon, Allergan, Alimera Sciences, Bayer, Thrombogenics; Consultant—Allergan, Alimera Sciences, Bayer, Pfizer; Honoraria from Alcon, Allergan, Alimera Sciences, Bayer, Novartis, Pfizer, and Thrombogenics; Advisory board—Novartis. M. Ohji: Grant—Alcon, Hoya Corp, Kowa Pharmaceutical, Novartis, Otsuka Pharmaceutical, Pfizer, Santen Pharmaceutical, Senju Pharmaceutical, and Topcon; Personal fees—Alcon, Allergan, Bayer, Bausch & Lomb, Carl Zeiss, Chugai Pharmaceutical, Chuo Sangio, Hoya Corp, Kowa Pharmaceutical, MSD, Novartis, Otsuka Pharmaceutical, Pfizer, RE Medical Inc, Santen Pharmaceutical, Senju Pharmaceutical, Sanwa Kagaku Kenkyusho, and Topcon. H. Dai: Research grants and nonfinancial support—Novartis. S. Sharma: Financial support—Alcon, Allergan, Bausch and Lomb, Bayer, Genentech, Health Canada, Novartis, Roche, and the Canadian Institutes of Health Research; Consultant—Alcon, Allergan, Bausch and Lomb, Bayer, Genentech, Health Canada, Novartis, Roche, and the Canadian Institutes of Health Research. C. Dunger-Baldauf: Employee—Novartis Pharma AG, Basel, Switzerland. S. Lacey: Employee—Novartis Pharmaceuticals UK Limited, Surrey, Frimley, Camberley, United Kingdom. W. Macfadden: Employee—Novartis Pharma AG, Basel, Switzerland. P. Mitchell: Consultant—Abbott, Allergan, Bayer, Genentech, Novartis, and Roche; Financial support—Abbott, Allergan, Bayer, Genentech, Novartis, and Roche. The remaining author has no conflict of interests to disclose.

Figures

Fig. 1.
Fig. 1.
LUMINOUS study overview: Overall worldwide recruitment and countries enrolling the highest number of treatment-naive patients with nAMD. The pop-out boxes display the number (%) of treatment-naive patients with nAMD in the top 10 enrolling countries for this cohort. nAMD, neovascular age-related macular degeneration; UK, United Kingdom.
Fig. 2.
Fig. 2.
Mean change in visual acuity from baseline to Year 1 by (A) injection frequency, (B) loading and nonloading dose, and (C) baseline visual acuity. Observed data set (primary treated eye set). Values in parentheses represent the Snellen visual acuity equivalent. *Total number of patients at enrollment from global cohort. †Total number of patients with baseline and Year 1 data from global cohort. ‡Number of evaluable patients with baseline and Year 1 data based on injection frequency category. **Number of evaluable patients with baseline and Year 1 data for 6 to 9 injection stratum. #Final visual acuity at Year 1. $Number of evaluable patients with baseline and Year 1 data based on the baseline visual acuity. Loading dose group is defined as the patients who received the three initial consecutive monthly ranibizumab injections up to Day 100. For treatment-naive eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year period, all patients with nonmissing baseline visual acuity and Year 1 visual acuity performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to the last follow-up date were included in the analysis. ETDRS, Early Treatment Diabetic Retinopathy Study.
Fig. 3.
Fig. 3.
Proportion of patients with loss or gain in visual acuity at Year 1. *Includes patients with 0 letters loss. Observed data set (primary treated eye set). Data shown for 3,379 patients with baseline and Year 1 data from global cohort. For treatment-naive eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year period, all patients with nonmissing baseline visual acuity and Year 1 visual acuity performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. ETDRS, Early Treatment Diabetic Retinopathy Study; nAMD, neovascular age-related macular degeneration.
Fig. 4.
Fig. 4.
Visual acuity outcomes at Year 1: country-specific analyses. Observed data set (primary treated eye set). Values in parentheses represent the Snellen visual acuity equivalent. N = total number of patients with baseline and Year 1 data from global cohort; n = number of evaluable patients from top 10 recruiting countries (treatment-naive nAMD) with highest evaluable baseline and Year 1 data. For treatment-naive eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year period, all patients with nonmissing baseline visual acuity and Year 1 visual acuity performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to the last follow-up date were included in the analysis. ETDRS, Early Treatment Diabetic Retinopathy Study.
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Comment in

  • Correspondence.
    Călugăru D, Călugăru M. Călugăru D, et al. Retina. 2020 Sep;40(9):e49-e51. doi: 10.1097/IAE.0000000000002908. Retina. 2020. PMID: 32842091 No abstract available.
  • Reply.
    Holz FG, Figueroa MS, Bandello F, Yang Y, Ohji M, Dai H, Wykrota H, Sharma S, Dunger-Baldauf C, Lacey S, Macfadden W, Mitchell P; all the LUMINOUS study investigators. Holz FG, et al. Retina. 2020 Sep;40(9):e51-e53. doi: 10.1097/IAE.0000000000002909. Retina. 2020. PMID: 32842092 No abstract available.

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