AZURE study shows efficacy of aflibercept treat-and-extend regimen in age-related macular degeneration
The efficacy and safety of the intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) regimen is safe and effective in comparison to fixed dosing for patients with neovascular age-related macular degeneration (nAMD), according to results from the AZURE study.
The T&E regimen, administered every 2 months with a flexible treatment interval, was shown to achieve similar functional and anatomic outcomes to the fixed dosing regimen over 52 weeks.
The randomized, open-label, parallel-group, Phase 3b study enrolled patients ≥ 51 years who had completed a minimum of 1 year of IVT-AFL treatment. The patients were then randomly assigned to either the IVT-AFL T&E group or a fixed dosing regimen group.
In the T&E group, patients received IVT-AFL every 2 months, with a minimum treatment interval of 8 weeks and no upper limit. The treatment frequency was adjusted based on functional and anatomic outcomes. The fixed dosing group received treatment every 8 weeks (± 3 days).
The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) from baseline to week 52. The key secondary endpoint focused on the proportion of patients maintaining vision (< 15-letter loss) at week 52.
The results, based on the full analysis set of 332 patients, found that the mean BCVA change from baseline to week 52 in the T&E group was -0.3 ± 7.5 letters, while the fixed dosing group showed a change of -0.5 ± 8.4 letters. The study demonstrated noninferiority (P < 0.0001) for the T&E regimen compared to fixed dosing, with a 5-letter margin.
Moreover, 95.2% of patients in the T&E group and 94.0% in the fixed dosing group maintained their vision from baseline to week 52. The mean central subfield thickness change from baseline to week 52 was -24 ± 55 µm in the T&E group and -33 ± 47 µm in the fixed dosing group.
The last treatment interval for T&E patients to week 76 was ≥ 12 weeks for 37.0% of the participants, showcasing the potential for reduced treatment burden without compromising outcomes.
No new safety signals were identified during the course of the study.
Reference
Kodjikian L, Arias Barquet L, Papp A, et al. Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing. Adv Ther. 2024;doi: 10.1007/s12325-023-02719-3. Epub ahead of print. PMID: 38183525.
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