Kang Yeun Pak1, Jae Pil Shin2, Hyun Woong Kim1, Min Sagong3, Yu Cheol Kim4, Sang Joon Lee5, In Young Chung6, Sung Who Park7,8, Ji Eun Lee9,10. 1. Department of Ophthalmology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea. 2. Department of Ophthalmology, Kyungpook National University School of Medicine, Deagu, Republic of Korea. 3. Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea. 4. Department of Ophthalmology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. 5. Department of Ophthalmology, Kosin University College of Medicine, Busan, Republic of Korea. 6. Department of Ophthalmology, Gyeongsang National University School of Medicine, Jinju, Republic of Korea. 7. Department of Ophthalmology, Pusan National University, College of Medicine, Yangsan, Republic of Korea. 8. Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea. 9. Department of Ophthalmology, Pusan National University, College of Medicine, Yangsan, Republic of Korea, jlee@pusan.ac.kr. 10. Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea, jlee@pusan.ac.kr.
Abstract
INTRODUCTION: The purpose of this study was to report the one-year results of treatment of diabetic macular edema (DME) with aflibercept using a treat-and-extend regimen (TER). METHODS: This was a prospective, multicenter, single-arm study planned for 2 years. The eyes received 5 consecutive intravitreal injections of 2 mg of aflibercept every 4 weeks, and the interval between injections was then adjusted by 2 weeks based on changes in the central subfield macular thickness (CSMT). If the CSMT was worse, stable, or better, the interval was shortened, extended, or maintained, respectively. The primary outcome measure was the change in best-corrected visual acuity (BCVA) from baseline to 104 weeks, and the secondary outcome was the change in BCVA from baseline to 52 weeks. RESULTS: Of the 48 patients enrolled, 46 completed a 1-year visit. BCVA improved significantly by 9.1 letters (95% confidence interval: 5.3-13.0 letters) from 56.2 letters at baseline (p < 0.001), and CSMT decreased by -171.7 μm from 489.4 to 317.7 μm (p < 0.001). The proportion of eyes having 20/40 or better vision increased from 17.4 to 41.3%, and the proportion of eyes that gained ≥15 letters was 28.3%. The mean number of injections was 8.5 times for 52 weeks. Worsening of macular edema did not occur in 76.1% of eyes during the extension period, and the interval between injections was extended to 12 weeks in 73.9% of eyes at 52 weeks. CONCLUSIONS: The TER showed 1-year efficacy comparable to that of the fixed dosing regimen of pivotal trials, and its flexible dosing would prevent overtreatment.
RCT Entities:
INTRODUCTION: The purpose of this study was to report the one-year results of treatment of diabetic macular edema (DME) with aflibercept using a treat-and-extend regimen (TER). METHODS: This was a prospective, multicenter, single-arm study planned for 2 years. The eyes received 5 consecutive intravitreal injections of 2 mg of aflibercept every 4 weeks, and the interval between injections was then adjusted by 2 weeks based on changes in the central subfield macular thickness (CSMT). If the CSMT was worse, stable, or better, the interval was shortened, extended, or maintained, respectively. The primary outcome measure was the change in best-corrected visual acuity (BCVA) from baseline to 104 weeks, and the secondary outcome was the change in BCVA from baseline to 52 weeks. RESULTS: Of the 48 patients enrolled, 46 completed a 1-year visit. BCVA improved significantly by 9.1 letters (95% confidence interval: 5.3-13.0 letters) from 56.2 letters at baseline (p < 0.001), and CSMT decreased by -171.7 μm from 489.4 to 317.7 μm (p < 0.001). The proportion of eyes having 20/40 or better vision increased from 17.4 to 41.3%, and the proportion of eyes that gained ≥15 letters was 28.3%. The mean number of injections was 8.5 times for 52 weeks. Worsening of macular edema did not occur in 76.1% of eyes during the extension period, and the interval between injections was extended to 12 weeks in 73.9% of eyes at 52 weeks. CONCLUSIONS: The TER showed 1-year efficacy comparable to that of the fixed dosing regimen of pivotal trials, and its flexible dosing would prevent overtreatment.
Authors: Nicole Eter; Rishi P Singh; Francis Abreu; Kemal Asik; Karen Basu; Caroline Baumal; Andrew Chang; Karl G Csaky; Zdenka Haskova; Hugh Lin; Carlos Quezada Ruiz; Paisan Ruamviboonsuk; David Silverman; Charles C Wykoff; Jeffrey R Willis Journal: Ophthalmol Sci Date: 2021-12-30
Authors: José Ignacio Fernández-Vigo; Inés Contreras; María José Crespo; Carlos Beckford; Ignacio Flores-Moreno; Rosario Cobo-Soriano; Jesús Pareja; María Dolores Martín; Luis Moreno; Luis Arrevola-Velasco Journal: Clin Ophthalmol Date: 2022-09-19