PMID- 27863845 OWN - NLM STAT- MEDLINE DCOM- 20170718 LR - 20220330 IS - 1549-4713 (Electronic) IS - 0161-6420 (Linking) VI - 124 IP - 2 DP - 2017 Feb TI - Macular Atrophy in Neovascular Age-Related Macular Degeneration with Monthly versus Treat-and-Extend Ranibizumab: Findings from the TREX-AMD Trial. PG - 215-223 LID - S0161-6420(16)31515-9 [pii] LID - 10.1016/j.ophtha.2016.10.002 [doi] AB - PURPOSE: 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. DESIGN: Eighteen-month, multicenter, randomized, controlled clinical trial. PARTICIPANTS: Sixty patients with treatment-naive neovascular AMD in 1 eye randomized 1:2 to monthly or TREX ranibizumab. METHODS: Patients' 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 MEASURES: Mean ERMA at 18 months. Relationship between visual acuity and MA, and the baseline risk factors for ERMA were also assessed. RESULTS: The 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 mm(2) (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 mm(2), 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 mum, P = 0.01) and SHRM thickness (106+/-131 vs. 50+/-85 mum, 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). CONCLUSIONS: Ranibizumab 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. CI - Copyright (c) 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. FAU - Abdelfattah, Nizar S AU - Abdelfattah NS AD - Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: nizar@ucla.edu. FAU - Al-Sheikh, Mayss AU - Al-Sheikh M AD - Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. FAU - Pitetta, Sean AU - Pitetta S AD - Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California. FAU - Mousa, Ahmed AU - Mousa A AD - Department of Ophthalmology, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia. FAU - Sadda, SriniVas R AU - Sadda SR AD - Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. FAU - Wykoff, Charles C AU - Wykoff CC AD - Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas. CN - Treat-and-Extend Age-Related Macular Degeneration Study Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20161115 PL - United States TA - Ophthalmology JT - Ophthalmology JID - 7802443 RN - 0 (Angiogenesis Inhibitors) RN - ZL1R02VT79 (Ranibizumab) SB - IM MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/*therapeutic use MH - Atrophy/pathology MH - Drug Administration Schedule MH - Female MH - Fluorescein Angiography MH - Humans MH - Intravitreal Injections MH - Macula Lutea/*pathology MH - Male MH - Middle Aged MH - Prevalence MH - Prospective Studies MH - Ranibizumab/*therapeutic use MH - Risk Factors MH - Tomography, Optical Coherence MH - United States/epidemiology MH - Visual Acuity MH - Wet Macular Degeneration/*drug therapy/epidemiology/*pathology FIR - Wykoff, Charles C IR - Wykoff CC FIR - Croft, Daniel E IR - Croft DE FIR - Brown, David M IR - Brown DM FIR - Wang, Rui IR - Wang R FIR - Payne, John F IR - Payne JF FIR - Clark, Lloyd IR - Clark L FIR - Abdelfattah, Nizar Saleh IR - Abdelfattah NS FIR - Sadda, SriniVas R IR - Sadda SR FIR - Benz, Matthew S IR - Benz MS FIR - Chen, Eric IR - Chen E FIR - Fish, Richard H IR - Fish RH FIR - Johnson, David L IR - Johnson DL FIR - Kim, Rosa Y IR - Kim RY FIR - Major, James C Jr IR - Major JC Jr FIR - O'Malley, Ronan E IR - O'Malley RE FIR - Schefler, Amy C IR - Schefler AC FIR - Shah, Ankoor R IR - Shah AR FIR - Vance, Sushma K IR - Vance SK FIR - Wells, John A 3rd IR - Wells JA 3rd FIR - Wong, Tien P IR - Wong TP EDAT- 2016/11/20 06:00 MHDA- 2017/07/19 06:00 CRDT- 2016/11/20 06:00 PHST- 2016/07/13 00:00 [received] PHST- 2016/09/29 00:00 [revised] PHST- 2016/10/03 00:00 [accepted] PHST- 2016/11/20 06:00 [pubmed] PHST- 2017/07/19 06:00 [medline] PHST- 2016/11/20 06:00 [entrez] AID - S0161-6420(16)31515-9 [pii] AID - 10.1016/j.ophtha.2016.10.002 [doi] PST - ppublish SO - Ophthalmology. 2017 Feb;124(2):215-223. doi: 10.1016/j.ophtha.2016.10.002. Epub 2016 Nov 15.