Abstract
Purpose :
Landmark trials of anti-VEGF treatment for macular edema due to branch (BRVO) and central retinal vein occlusion (CRVO) show that clinically significant vision gains are achievable with frequent initial injections, monthly monitoring, and timely re-treatment; however, this is burdensome and not feasible in clinical practice. This study assessed the impact of anti-VEGF injections and monitoring frequency on BCVA outcomes in patients with BRVO and CRVO.
Methods :
This was a cross-trial comparison between controlled clinical trials, long-term extension (LTE) trials, and real-world studies of anti-VEGF therapy in patients with macular edema due to BRVO or CRVO. Published data were used to compare average 12-month injection frequencies and BCVA outcomes achieved with fixed, as-needed, treat-and-extend, and real-world anti-VEGF treatment regimens; and with monthly or less-frequent monitoring visits.
Results :
Analyses included 7 controlled clinical trials (2 BRVO, 5 CRVO; all with monthly monitoring), 4 LTE trials (2 BRVO/CRVO, 2 CRVO; most with less-than-monthly monitoring), and 2 real-world studies (both BRVO/CRVO; monitored per investigator discretion). Patients with BRVO in clinical trials received 8.5–9.0 injections over 12 months versus 1.6–4.9 injections in LTE trials and real-world studies. In clinical trials, mean BCVA change over 12 months was 17.1–18.3 letters versus –0.7 to –2.1 letters in LTE trials with less-frequent visits. Mean BCVA change over 12 months in real-world BRVO studies was only 7.7–13.1 letters. Patients with CRVO in clinical trials received 7.8–11.8 injections over 12 months versus 1.5–5.1 injections in LTE trials and real-world studies. Patients with CRVO in clinical trials gained 10.7–21.9 letters over 12 months. However, these gains were not maintained in LTE trials (–7.6 to 0.2 letters), nor achieved in real-world studies (4.1–7.1 letters).
Conclusions :
In real-world studies, patients with BRVO or CRVO were monitored less frequently, received fewer anti-VEGF injections, and did not achieve the BCVA gains seen in clinical trials. Likewise, patients who achieved vision gains in clinical trials on average experienced BCVA loss with fewer follow-up visits in LTE trials. These data highlight the need for new strategies that extend the durability of treatment to reduce treatment burden and need for frequent monitoring, and to improve real-world vision outcomes.
This is a 2021 ARVO Annual Meeting abstract.