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

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.

Conflict of interest statement

Heidi Brié, Eva Ramboer and Mérédis Favreau are employees of Novartis Pharma. Kris Denhaerynck, Karen MacDonald, and Ivo Abraham are associated with Matrix45, with Karen MacDonald and Ivo Abraham holding equity in Matrix45, which was hired by Novartis Pharma to develop study protocols, conduct statistical analyses and develop study reports and manuscripts for other ophthalmology projects outside the submitted work. By company policy, Matrix45 associates are prohibited from owning equity in sponsor organizations (except through mutual funds or other independently administered investment instruments) or contracting independently with sponsor organizations. Matrix45 provides similar services to those described in this paper to other companies on a non-exclusivity basis. The authors report no other conflicts of interest in this work.

© 2020 Leys et al.

Figures

Figure 1

Mean VA change (in ETDRS letters ± standard errors) from baseline per quarter. Notes: Pre-treatment status category of the eye: Treatment-naïve= ; Prior ranibizumab = . Baseline n (month 0)=number of patients; all other n=number of measurements within the quarter (multiple assessments per patient possible). Abbreviations: ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.

Figure 2

Mean CRT change (in µm ± standard errors) from baseline per quarter. Notes: Pre-treatment status category of the eye: Treatment-naïve= ; Prior ranibizumab = . Baseline n (month 0)=number of patients; all other n=number of measurements within the quarter (multiple assessments per patient possible). Abbreviations: CRT, central retinal thickness; µm, micrometer.