Macular Atrophy in Neovascular Age-Related Macular Degeneration with Monthly versus Treat-and-Extend Ranibizumab: Findings from the TREX-AMD Trial

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• 作者：Nizar S. Abdelfattah ; MD¹ ; ² ; ^{nizar@ucla.edu} ; Mayss Al-Sheikh ; MD¹ ; ² ; Sean Pitetta ; BS¹ ; Ahmed Mousa ; PhD³ ; SriniVas R. Sadda ; MD¹ ; ² ; Charles C. Wykoff ; MD ; PhD⁴ ; ⁵ ; on behalf of the Treat-and-Extend Age-Related Macular Degeneration Study Group^&lowast ; ; Charles C. Wykoff ; MD ; PhD ; Daniel E. Croft ; BA ; David M. Brown ; MD ; Rui Wang ; BA ; John F. Payne ; MD ; Lloyd Clark ; MD ; Nizar Saleh Abdelfattah ; MD ; SriniVas R. Sadda ; MD ; Matthew S. Benz ; MD ; Eric Chen ; MD ; Richard H. Fish ; MD ; David L. Johnson ; MD ; Rosa Y. Kim ; MD ; James C. Major Jr. ; MD ; Ronan E. O'Malley ; MD ; Amy C. Schefler ; MD ; Ankoor R. Shah ; MD ; Sushma K. Vance ; MD ; John A. Wells III ; MD ; Tien P. Wong ; MD
• 关键词：AMD ; age-related macular degeneration ; CATT ; Comparison of AMD Treatments Trials ; CNV ; choroidal neovascularization ; ERMA ; enlargement rate of macular atrophy ; FAF ; fundus autofluorescence ; FCT ; foveal choroidal thickness ; GA ; geographic atrophy ; MA ; macular atrophy ; PED ; pigment epithelial detachment ; RPE ; retinal pigment epithelium ; SHRM ; subretinal hyperreflective material ; SRF ; subretinal fluid ; TREX ; treat-and-extend ; TREX-AMD ; Treat-and-Extend Age-Related Macular Degeneration ; VEGF ; vascul
• 刊名：Ophthalmology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：124
• 期：2
• 页码：215-223
• 全文大小：1863 K
• 卷排序：124

文摘

To compare the enlargement rate of macular atrophy (ERMA) in eyes treated with ranibizumab monthly or using a treat-and-extend (TREX) regimen for neovascular age-related macular degeneration (AMD) or fellow control eyes, as well as analyze risk factors for macular atrophy (MA) development and progression.DesignEighteen-month, multicenter, randomized, controlled clinical trial.ParticipantsSixty patients with treatment-naïve neovascular AMD in 1 eye randomized 1:2 to monthly or TREX ranibizumab.MethodsPatients' study and fellow eyes were followed for 18 months using spectral-domain optical coherence tomography (SD OCT) and fundus autofluorescence (FAF) imaging. The MA was quantified on FAF images using Heidelberg Region Finder software (Heidelberg Engineering, Heidelberg, Germany), with suspected areas of atrophy confirmed by SD OCT and infrared reflectance imaging. For eyes without baseline MA yet developed MA by 18 months, intervening visits were assessed to determine the first visit at which MA appeared to define progression rates. Foveal choroidal thickness (FCT), subretinal hyperreflective material (SHRM), and pigment epithelial detachment (PED), were assessed at baseline to determine whether they influenced MA progression.Main Outcome MeasuresMean ERMA at 18 months. Relationship between visual acuity and MA, and the baseline risk factors for ERMA were also assessed.ResultsThe final analysis cohort included 88 eyes in 3 groups: monthly (n = 19), TREX (n = 30), and control fellow eyes (n = 39). Mean ERMA over 18 months was 0.39±0.67 (monthly), 1.1±1.9 (TREX), and 0.49±1 mm2 (control, P = 0.12). Mean ERMA per group among the 40.9% (n = 36) of baseline patients with MA was 0.9±1, 1.9±2.2, and 1±1.3 mm2, respectively (P = 0.31). The incidence rate of MA in the 3 groups was 40%, 0%, and 8.3%, respectively. Mann–Whitney U test revealed a statistically significant association between baseline FCT (127±46 vs. 155±55 μm, P = 0.01) and SHRM thickness (106±131 vs. 50±85 μm, P = 0.02) on MA. In eyes with no baseline MA, presence of SHRM, SHRM, and PED thickness, and presence of baseline hemorrhage were all significant predictors of new MA development (P = 0.04, 0.01, 0.04, 0.004, 0.01, respectively).ConclusionsRanibizumab did not show a statistically significant influence on new MA development in eyes with neovascular AMD, whether dosed monthly or per TREX regimen. The FCT, SHRM thickness, and hemorrhage at baseline were all significant predictors of new MA.