María Isabel López Gálvez1, Lluís Arias Barquet2, Marta S Figueroa3, Alfredo García-Layana4, José M Ruiz Moreno5. 1. Department of Ophthalmology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 2. Department of Ophthalmology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. 3. Department of Ophthalmology, Hospital Universitario Ramón y Cajal, Madrid, Spain. 4. Department of Ophthalmology, Clínica Universidad de Navarra, Pamplona, Spain. 5. Department of Ophthalmology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Abstract
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.
RCT Entities:
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&Eranibizumab were noninferior to PRN in naïve nAMD.
Authors: Voraporn Chaikitmongkol; Min Sagong; Timothy Y Y Lai; Gavin S W Tan; Nor Fariza Ngah; Masahito Ohji; Paul Mitchell; Chang-Hao Yang; Paisan Ruamviboonsuk; Ian Wong; Taiji Sakamoto; Anand Rajendran; Youxin Chen; Dennis S C Lam; Chi-Chun Lai; Tien Yin Wong; Chui Ming Gemmy Cheung; Andrew Chang; Adrian Koh Journal: Asia Pac J Ophthalmol (Phila) Date: 2021-11-24