Ophthalmology and therapy · 2025
The Impact of Disease Activity Criteria on Extending Injection Intervals in Real-World Patients with Neovascular Age-Related Macular Degeneration.
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Bhatia Bhairavi, Sim Sing Yue, Chalkiadaki Evangelia, Koutsocheras Georgios, Nicholson Luke, Selvam Senthil, Sivaprasad Sobha, Pal Bishwanath, Huemer Josef, Keane Pearse A, Hamilton Robin, Patel Praveen J, Moorfields Medical Retina Injection Service
Аннотация
INTRODUCTION: In clinical practice, intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection intervals for patients with neovascular age-related macular degeneration (nAMD) are based on disease activity, with active or recurrent disease requiring more frequent injections. Injection interval modification criteria differ from those used in clinical trials, thereby potentially affecting treatment outcomes. This analysis evaluated the potential impact of applying disease activity criteria from recent clinical trials (TENAYA/LUCERNE; HAWK/HARRIER; PULSAR) on the decision to extend injection intervals in real-world patients commenced on faricimab after the loading phase of treatment and at 12 months.
METHODS: Data were analysed from 105 treatment-naïve patients with nAMD who received anti-VEGF injections at Moorfields Eye Hospital. Disease activity criteria from TENAYA/LUCERNE, HAWK/HARRIER and PULSAR clinical trials were applied to determine the hypothetical impact on the decision to modify injection intervals at week 12 (fourth injection) and 12-month real-world clinic visits.
RESULTS: At 12 weeks, 79% of patients had injection intervals extended in clinical practice compared to 80% when applying hypothetical TENAYA/LUCERNE disease activity criteria; 77% using HAWK/HARRIER and 96% using PULSAR. There was agreement between clinical practice and all clinical trials in 60% of eyes, and no agreement in 13%. At 12 months, fewer patients were inactive, with 55% of eyes quiescent in clinical practice, 58% when applying TENAYA/LUCERNE criteria and 67% using HAWK/HARRIER. Application of PULSAR disease activity criteria showed 96% of patients were classed as inactive. 34% of eyes showed agreement in disease activity status between clinical practice and all clinical trials at 12 months, with no agreement in 20%.
CONCLUSIONS: Applying disease activity criteria from clinical trials to clinical practice can have a significant impact on hypothetical anti-VEGF injection intervals. Consideration should be paid to which criteria are used in real-world practice to help achieve treatment burden reductions and optimal treatment outcomes seen in clinical trials.
METHODS: Data were analysed from 105 treatment-naïve patients with nAMD who received anti-VEGF injections at Moorfields Eye Hospital. Disease activity criteria from TENAYA/LUCERNE, HAWK/HARRIER and PULSAR clinical trials were applied to determine the hypothetical impact on the decision to modify injection intervals at week 12 (fourth injection) and 12-month real-world clinic visits.
RESULTS: At 12 weeks, 79% of patients had injection intervals extended in clinical practice compared to 80% when applying hypothetical TENAYA/LUCERNE disease activity criteria; 77% using HAWK/HARRIER and 96% using PULSAR. There was agreement between clinical practice and all clinical trials in 60% of eyes, and no agreement in 13%. At 12 months, fewer patients were inactive, with 55% of eyes quiescent in clinical practice, 58% when applying TENAYA/LUCERNE criteria and 67% using HAWK/HARRIER. Application of PULSAR disease activity criteria showed 96% of patients were classed as inactive. 34% of eyes showed agreement in disease activity status between clinical practice and all clinical trials at 12 months, with no agreement in 20%.
CONCLUSIONS: Applying disease activity criteria from clinical trials to clinical practice can have a significant impact on hypothetical anti-VEGF injection intervals. Consideration should be paid to which criteria are used in real-world practice to help achieve treatment burden reductions and optimal treatment outcomes seen in clinical trials.