Mark C Gillies1, Alex P Hunyor2, Jennifer J Arnold3, Robyn H Guymer4, Sebastian Wolf5, Francois L Pecheur6, Marion R Munk5, Ian L McAllister7. 1. Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au. 2. Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia; Retina Associates, Chatswood, Australia. 3. Marsden Eye Specialists, Parramatta, Australia. 4. Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. 5. Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. 6. Healthcare Professionals Group Pty Ltd, Sydney, Australia. 7. Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia.
Abstract
PURPOSE: To investigate differences in the development of macular atrophy (MA) over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in patients with neovascular age-related macular degeneration (nAMD). DESIGN: A phase 4 randomized, partially masked, multicenter study. PARTICIPANTS: Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more. METHODS: Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading center-guided T&E regimen after 3 initial monthly injections. MAIN OUTCOME MEASURES: The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24. RESULTS:Two hundred seventy-eight patients were included in the analysis (ranibizumab 0.5 mg, n = 141; aflibercept 2.0 mg, n = 137). Mean change in square root area of MA from baseline to month 24 was +0.36 mm (95% confidence interval [CI], 0.27-0.45 mm) for ranibizumab and +0.28 mm (95% CI, 0.19-0.37 mm) for aflibercept (treatment difference, +0.08 mm [95% CI, -0.05 to 0.21 mm]; P = 0.24). The proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for ranibizumab and from 6% (8/137) to 32% (35/108) for aflibercept from baseline to month 24. The average number of injections received per year was similar between both groups: 9.6 (95% CI, 9.2-10.0) for ranibizumab and 9.5 (95% CI, 9.1-9.9) for aflibercept. The mean change in BCVA from baseline to month 24 was +6.6 letters (95% CI,4.7-8.5 letters) for the ranibizumab group and +4.6 letters (95% CI, 2.7-6.6 letters) for the aflibercept group ( P = 0.15). Rates of adverse events (AEs) were similar between both groups. CONCLUSIONS: No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.
RCT Entities:
PURPOSE: To investigate differences in the development of macular atrophy (MA) over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in patients with neovascular age-related macular degeneration (nAMD). DESIGN: A phase 4 randomized, partially masked, multicenter study. PARTICIPANTS: Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more. METHODS:Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading center-guided T&E regimen after 3 initial monthly injections. MAIN OUTCOME MEASURES: The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24. RESULTS: Two hundred seventy-eight patients were included in the analysis (ranibizumab 0.5 mg, n = 141; aflibercept 2.0 mg, n = 137). Mean change in square root area of MA from baseline to month 24 was +0.36 mm (95% confidence interval [CI], 0.27-0.45 mm) for ranibizumab and +0.28 mm (95% CI, 0.19-0.37 mm) for aflibercept (treatment difference, +0.08 mm [95% CI, -0.05 to 0.21 mm]; P = 0.24). The proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for ranibizumab and from 6% (8/137) to 32% (35/108) for aflibercept from baseline to month 24. The average number of injections received per year was similar between both groups: 9.6 (95% CI, 9.2-10.0) for ranibizumab and 9.5 (95% CI, 9.1-9.9) for aflibercept. The mean change in BCVA from baseline to month 24 was +6.6 letters (95% CI,4.7-8.5 letters) for the ranibizumab group and +4.6 letters (95% CI, 2.7-6.6 letters) for the aflibercept group ( P = 0.15). Rates of adverse events (AEs) were similar between both groups. CONCLUSIONS: No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.
Authors: Kevin Schneider; Marilyn Chwa; Shari R Atilano; Zixuan Shao; John Park; Hampar Karageozian; Vicken Karageozian; M Cristina Kenney Journal: Exp Eye Res Date: 2020-10-16 Impact factor: 3.770
Authors: S W Quist; L A de Jong; F van Asten; P Knoester; M J Postma; R D Freriks Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-10-13 Impact factor: 3.117
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