Real-world outcomes in patients with diabetic macular edema treated long term with ranibizumab (Vision study)

Elisabeth Van Aken, Mérédis Favreau, Eva Ramboer, Kris Denhaerynck, Karen Macdonald, Ivo Abraham, Heidi Brié

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Aim: Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab. Methods: Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5±1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis. Results: The mean±SD number of treatments in the first year was 5.1±3.0 (TX-naïve), 4.5 ±2.7 (PRIOR-anti-VEGF) and 5.6±3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in TX-naïve (p<0.0001), by 11.8±9.9 from 61.6 ±8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2±10.6 from 58.2±14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of −43.8µm in TX-naïve (p=0.04), −75.7µm in PRIOR-anti-VEGF (p=0.02), and −65.8µm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment. Conclusion: This real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns.

Original languageEnglish (US)
Pages (from-to)4173-4185
Number of pages13
JournalClinical Ophthalmology
Volume14
DOIs
StatePublished - 2020

Keywords

  • Best-corrected visual acuity
  • Central retinal thickness
  • Diabetic macular edema
  • Long-term effectiveness
  • Ranibizumab

ASJC Scopus subject areas

  • Ophthalmology

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