Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study

Purpose To assess the noninferiority of the treat‐and‐extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in naïve patients with neovascular age‐related macular degeneration (nAMD). Methods Phase IV, randomized, 12‐month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best‐corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n  = 103, T&E, n  = 99 or PRN, n  = 104. Noninferiority was established at five letters ETDRS. Results The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2–10.2), 6.4 (2.9–9.8), and 8.0 (51.1–11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5–7.7) was similar as compared with the PRN regimen (7.4, 6.7–8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9–9.7) (p < 0.001). Conclusion At 12 months, bimonthly and T&E ranibizumab were noninferior to PRN in naïve nAMD.