Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study

Anita M Leys; Eva Ramboer; Mérédis Favreau; Kris Denhaerynck; Karen MacDonald; Ivo Abraham; Heidi Brié

doi:10.2147/OPTH.S242547

Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUS^TM Study

Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.

Authors

Anita M Leys^{1

2}, Eva Ramboer³, Mérédis Favreau³, Kris Denhaerynck^{4

5}, Karen MacDonald⁴, Ivo Abraham^{4

6

7

8}, Heidi Brié³

Affiliations

¹ Department of Ophthalmology, Universitair Ziekenhuis Gasthuisberg, KULeuven, Leuven, Belgium.
² Oogartsen, Alken, Belgium.
³ Novartis Pharma, Vilvoorde, Belgium.
⁴ Matrix45, Tucson, AZ, USA.
⁵ Department of Public Health, University of Basel, Basel, Switzerland.
⁶ Center for Health Outcomes and Pharmacoeconomic Research, University of Arizona, Tucson, AZ, USA.
⁷ Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ, USA.
⁸ Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, AZ, USA.

Abstract

Purpose: To evaluate long-term, real-world treatment patterns and outcomes of ranibizumab 0.5 mg for neovascular age-related macular degeneration (nAMD) in a Belgian cohort.

Patients and methods: This Belgian (BE) cohort of the 5-year global observational LUMINOUS study included 229 patients with nAMD. Outcomes included visual acuity (VA), central retinal thickness (CRT) and safety.

Results: The mean age was 79.5±7.7 years. The majority of patients (67.7%) were female and all patients were Caucasian. Most patients previously received ranibizumab with only 17.5% of patients being treatment-naïve. The injection frequency declined over time irrespective of prior treatment status (p<0.0001), with treatment-naïve eyes receiving a mean of 4.2±2.9 yearly injections and prior-ranibizumab eyes 3.6±2.7. Regression analysis confirmed first-year VA increases for treatment-naïve eyes (p=0.002) followed by a slight decrease of -1.8 letters per year. For prior-ranibizumab eyes, the visual changes over 1 year were statistically non-significant (p=0.90) but declined slightly after year one (p<0.0001). Anatomically, the CRT of treatment-naïve eyes decreased over time from baseline (p<0.0001), whereas the CRT of prior-ranibizumab eyes remained stable (p=0.43). No new safety findings were identified.

Conclusion: LUMINOUS-BE reconfirms the well-characterized benefit-risk profile of ranibizumab for nAMD treatment. The observed low injection frequency reflects a need for more rigorous treatment in real-world settings.

Clinical trial registration: NCT01318941.

Keywords: Belgium; effectiveness; neovascular age-related macular degeneration; ranibizumab; safety; treatment patterns.

Associated data

ClinicalTrials.gov/NCT01318941

Grant support

This study and manuscript was funded by Novartis Pharma AG, Basel, Switzerland. The funding organization participated in the design of the study and the preparation, review and approval of the manuscript.