Akira Haga1, Takahiro Kawaji1,2, Ryuichi Ideta3, Yasuya Inomata1, Hidenobu Tanihara1. 1. Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan. 2. Sato Eye and Internal Medicine Clinic, Kumamoto, Japan. 3. Ideta Eye Hospital, Kumamoto, Japan.
Abstract
PURPOSE: To compare the 1-year outcomes of treat-and-extend (TAE) and every-other-month (2M) regimens with intravitreal aflibercept in Japanese wet age-related macular degeneration (AMD) patients. METHODS: Prospective, multicenter, randomized clinical trial. The primary outcome measure was the proportion of eyes in which the best-corrected visual acuity (BCVA) was maintained at week 52 [with a loss of <0.3 logarithm of minimum angular of resolution (logMAR) units]. The secondary outcome measures were the mean change from baseline in the central retinal thickness (CRT) and the number of injections. RESULTS:Forty-one patients were enrolled. The mean changes in the BCVA from baseline in the TAE and 2M were -0.32 ± 0.27 and -0.26 ± 0.30 logMAR units (p = 0.46). The TAE group was noninferior to the 2M group in BCVA maintenance. The mean CRT changes from baseline in the TAE and 2M were -161 ± 133 and -157 ± 90 μm (p = 0.73). The mean number of injections in the TAE and 2M were 7.5 ± 1.2 (range, 7-12) and 8.0 ± 0.0 (p < 0.0001). CONCLUSION: Treat-and-extend (TAE) regimen with aflibercept improved the BCVA and CRT to the same extent as 2M regimen, with a reduced number of injections.
RCT Entities:
PURPOSE: To compare the 1-year outcomes of treat-and-extend (TAE) and every-other-month (2M) regimens with intravitreal aflibercept in Japanese wet age-related macular degeneration (AMD) patients. METHODS: Prospective, multicenter, randomized clinical trial. The primary outcome measure was the proportion of eyes in which the best-corrected visual acuity (BCVA) was maintained at week 52 [with a loss of <0.3 logarithm of minimum angular of resolution (logMAR) units]. The secondary outcome measures were the mean change from baseline in the central retinal thickness (CRT) and the number of injections. RESULTS: Forty-one patients were enrolled. The mean changes in the BCVA from baseline in the TAE and 2M were -0.32 ± 0.27 and -0.26 ± 0.30 logMAR units (p = 0.46). The TAE group was noninferior to the 2M group in BCVA maintenance. The mean CRT changes from baseline in the TAE and 2M were -161 ± 133 and -157 ± 90 μm (p = 0.73). The mean number of injections in the TAE and 2M were 7.5 ± 1.2 (range, 7-12) and 8.0 ± 0.0 (p < 0.0001). CONCLUSION: Treat-and-extend (TAE) regimen with aflibercept improved the BCVA and CRT to the same extent as 2M regimen, with a reduced number of injections.
Authors: Laurent Kodjikian; Mariacristina Parravano; Andreas Clemens; Rosa Dolz-Marco; Frank G Holz; Marion R Munk; Massimo Nicolò; Federico Ricci; Rufino Silva; S James Talks; Rohini Kumar Verma; Javier Zarranz-Ventura; Sandrine A Zweifel Journal: Eye (Lond) Date: 2021-04-01 Impact factor: 3.775