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

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)-naive, 9.1% non-naive with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naive 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-naive), 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-naive (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 -43.8 mu m in TX-naive (p=0.04), -75.7 mu m in PRIOR-anti-VEGF (p=0.02), and -65.8 mu m 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.

Publication year:2020

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