@article{bb080e7a990d45f5a3a5be85d28d7507,
title = "Randomized Trial of Treat and Extend Ranibizumab With and Without Navigated Laser Versus Monthly Dosing for Diabetic Macular Edema: TREX-DME 2-Year Outcomes",
abstract = "Purpose: To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. Design: This was a multicenter, randomized, clinical trial. Methods: One hundred fifty eyes were randomized into 3 cohorts: monthly (n = 30), treat and extend without laser photocoagulation (TREX; n = 60), and treat and extend with angiography-guided laser photocoagulation (GILA; n = 60). Monthly cohort eyes received ranibizumab 0.3 mg every 4 weeks. TREX and GILA cohort eyes received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend dosing strategy. GILA cohort eyes also received navigated focal laser at month 1 and again every 3 months as needed. The primary outcomes included the mean change in best-corrected visual acuity and central retinal thickness and the number of injections from baseline to 2 years. Results: At 2 years, mean best-corrected visual acuity and central retinal thickness improved by 7.5, 9.6, and 9.0 letters (P = .75) and 139, 140, and 175 μm (P = .09), in the monthly, TREX, and GILA cohorts, respectively. The mean number of injections was significantly reduced in both the TREX (18.9) and GILA (17.5) cohorts compared with the monthly cohort (24.7, P < .001). Between the TREX and GILA cohorts, there was no significant difference in the mean treatment interval, mean maximal treatment interval, or percentage of eyes extended to 12 weeks. The total 2-year incidence of Anti-Platelet Trialists{\textquoteright} Collaboration events was 6.7%. Conclusion: The treat and extend algorithm of ranibizumab in the TREX-DME trial resulted in significantly fewer injections and yielded visual and anatomic gains comparable to monthly dosing at 2 years.",
author = "{TREX-DME Study Group} and Payne, {John F.} and Wykoff, {Charles C.} and Clark, {W. Lloyd} and Bruce, {Beau B.} and Boyer, {David S.} and Brown, {David M.} and Wells, {John A.} and Johnson, {David L.} and Matthew Benz and Eric Chen and Fish, {Richard H.} and Kim, {Rosa Y.} and Major, {James C.} and O'Malley, {Ronan E.} and Schefler, {Amy C.} and Shah, {Ankoor R.} and Wong, {Tien P.} and Novack, {Roger L.} and Chu, {Thomas G.} and Firas Rahhal and Homayoun Tabandeh and Roe, {Richard H.} and Dayani, {Pouya N.} and David Liao and Alexander Walsh and Esmaili, {Daniel D.}",
note = "Funding Information: All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Financial Disclosures: J.F.P. has received grant support from Genentech/Roche, Regeneron, OD-OS, Clearside Biomedical, Iconic Pharmaceuticals, Jaeb Center for Health Research, National Eye Institute, Neurotech, Ophthotech, Ophthea, and Santen. C.C.W. has been a consultant for Alcon, Allergan, Alimera, Bayer, Clearside Biomedical, Dutch Ophthalmic Research Center, Genentech, Regeneron, and Roche; has received grant support from Alcon, Allergan, Clearside Biomedical, Genentech, Heidelberg, Novartis, Regeneron, and Roche; and has received lecture fees from Allergan, Bayer, and Regeneron. W.L.C. has been a consultant for Regeneron, Genentech/Roche, OHR, and Santen; has received grant support from Regeneron, Genentech/Roche, Ophthotech, and Santen; and has received lecture fees from Genentech/Roche and Regeneron. B.B.B. has been a consultant for Medimmune and The Data and Safety Monitoring Board service and has received grants from the National Eye Institute (P30-EY006360) and the National Institute of Neurological Disorders and Stroke (R01-NS089694). D.S.B. has been a consultant for Genentech, Optovue, Regeneron, Roche, Novartis, Alcon, Allergan, and Bayer and has received lecture fees from Allergan. D.M.B. has been a consultant for Adverum, Clearside Biomedical, Novartis, Bayer, Genentech, Heidelberg, Regeneron, Roche, Santen, Samsung, Senju, Optos, Zeiss, Ohr Pharmaceuticals, Regenxbio, Chengdukanghong Biotechnology, Apellis, and Stealth Biotherapeutics. Funding/Support: Publication of this article was supported by a research grant from Genentech (ML28724). The funding organizations had no role in the design or conduct of this research. All authors attest that they meet the current ICMJE criteria for authorship. Funding Information: All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Financial Disclosures: J.F.P. has received grant support from Genentech /Roche, Regeneron, OD-OS, Clearside Biomedical, Iconic Pharmaceuticals, Jaeb Center for Health Research, National Eye Institute, Neurotech, Ophthotech, Ophthea, and Santen. C.C.W. has been a consultant for Alcon, Allergan, Alimera, Bayer, Clearside Biomedical, Dutch Ophthalmic Research Center, Genentech, Regeneron, and Roche; has received grant support from Alcon, Allergan, Clearside Biomedical, Genentech, Heidelberg, Novartis, Regeneron, and Roche; and has received lecture fees from Allergan, Bayer, and Regeneron. W.L.C. has been a consultant for Regeneron, Genentech/Roche, OHR, and Santen; has received grant support from Regeneron , Genentech / Roche , Ophthotech , and Santen ; and has received lecture fees from Genentech/Roche and Regeneron. B.B.B. has been a consultant for Medimmune and The Data and Safety Monitoring Board service and has received grants from the National Eye Institute ( P30-EY006360 ) and the National Institute of Neurological Disorders and Stroke ( R01-NS089694 ). D.S.B. has been a consultant for Genentech, Optovue, Regeneron, Roche, Novartis, Alcon, Allergan, and Bayer and has received lecture fees from Allergan. D.M.B. has been a consultant for Adverum, Clearside Biomedical, Novartis, Bayer, Genentech, Heidelberg, Regeneron, Roche, Santen, Samsung, Senju, Optos, Zeiss, Ohr Pharmaceuticals, Regenxbio, Chengdukanghong Biotechnology, Apellis, and Stealth Biotherapeutics. Funding/Support: Publication of this article was supported by a research grant from Genentech ( ML28724 ). The funding organizations had no role in the design or conduct of this research. All authors attest that they meet the current ICMJE criteria for authorship. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",
year = "2019",
month = jun,
doi = "10.1016/j.ajo.2019.02.005",
language = "English (US)",
volume = "202",
pages = "91--99",
journal = "American Journal of Ophthalmology",
issn = "0002-9394",
publisher = "Elsevier",
}