Original articleRandomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes
Section snippets
Methods
The Treat and Extend Protocol in Patients with Diabetic Macular Edema (TREX-DME) is a phase I/II, multicenter, randomized, controlled clinical trial. The protocol was registered at www.clinicaltrials.gov (NCT01934556). The study protocol and procedures were approved by a centralized institutional review board and conducted at Palmetto Retina Center (West Columbia, SC), Retina Consultants of Houston (Houston, TX), and Retina-Vitreous Associates Medical Group (Los Angeles, CA). All study conduct
Results
A total of 150 eyes were enrolled between November 2013 and April 2015. Baseline demographics at screening were well balanced among the 3 cohorts (Table 1). At baseline, mean age was 59 years (range, 33–82 years), and 57% (68/119) were male. A total of 137 eyes (91%) completed the 1-year end point visit. At baseline, 14 (47%) Monthly eyes, 33 (55%) TREX eyes, and 32 (53%) GILA eyes had a BCVA worse than 20/40. In addition, 16 (53%) Monthly eyes, 40 (67%) TREX eyes, and 35 (58%) GILA eyes had a
Discussion
Although treat and extend dosing of anti-VEGF medications has been studied and is commonly used for neovascular age-related macular degeneration, this approach has not been rigorously investigated for DME.10 The current study, TREX-DME, is the first randomized, controlled trial assessing the efficacy of a treat and extend dosing strategy of ranibizumab 0.3 mg for DME. In TREX-DME, treat and extend dosing with and without navigated laser photocoagulation significantly decreased treatment burden
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Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s): J.F.P.: Grants – Genentech, Regeneron, Alcon, Aerpio, EMMES.
C.C.W.: Grants – Alcon, Allergan, Bayer, Genentech, Regeneron, Roche, Allegro Ophthalmic, Apellis Pharmaceuticals, DRCR Network, Iconic Therapeutics; Personal fees – Alcon, Allergan, Alimera, Bayer, Genentech, Regeneron, Roche, Thrombogenics, Valeant.
W.L.C.: Grants – Regeneron, Genentech, Allergan; Personal fees – Bayer, Regeneron, Genentech, Santen, Ohr.
D.S.B.: Grants – Allergan, Aerpio, OHR, Regeneron, Genentech, River Vision, OD-OS, Kalvista; Personal fees – Allergan, Aerpio, Allegro, Bayer, OHR, Novartis, Regeneron, Genentech, Santen, River Vision, OD-OS.
D.M.B.: Grants – Alcon/Novartis, Allergan, Bayer, Genentech, Regeneron, Roche, Allegro Ophthalmic, Apelli Pharmaceuticals, DRCR Network, Iconic Therapeutics; Personal fees – Alcon/Novartis, Allergan, Alimera, Bayer, Genentech, Regeneron, Roche, Thrombogenics, Valeant.
Supported by a research grant from Genentech (grant no. ML28724). The funding organization had no role in the design or conduct of this research. Trial Registration: Registered at www.clinicaltrials.gov (NCT01934556).
Author Contributions:
Conception and design: Payne, Wykoff, Clark, Boyer, Brown
Data collection: Payne, Wykoff, Clark, Boyer, Brown
Analysis and interpretation: Payne, Wykoff, Clark, Bruce, Boyer, Brown
Obtained funding: Not applicable
Overall responsibility: Payne, Wykoff, Clark, Bruce, Boyer, Brown
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Members of the TREX-DME Study Group available in the Appendix (www.aaojournal.org).