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Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results
  1. John F. Payne1,
  2. Charles C. Wykoff2,
  3. W. Lloyd Clark1,
  4. Beau B. Bruce3,
  5. David S. Boyer4,
  6. David M. Brown5
  7. TREX-DME Study Group
    1. 1Palmetto Retina Center, West Columbia, South Carolina, USA
    2. 2Blanton Eye Institute, Houston Methodist Hospital and Weill Cornell Medical College, Retina Consultants of Houston, Houston, Texas, USA
    3. 3Department of Ophthalmology, Emory University, Atlanta, Georgia, USA
    4. 4Ophthalmology, University of Southern California, Sherman Oaks, California, USA
    5. 5The Methodist Hospital, Houston, TX, Houston, Texas, USA
    1. Correspondence to Dr John F. Payne, Palmetto Retina, West Columbia, South Carolina, USA; jpayne{at}palmettoretina.com

    Abstract

    Background/aims To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME).

    Methods This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 µm, and all eyes were eligible to receive focal laser.

    Results 109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year.

    Conclusion The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections.

    Trial registration number FDA IND 119146, NCT01934556.

    • retina
    • treatment medical
    • treatment lasers
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    Footnotes

    • Presented at Presented at the annual meeting of the American Academy of Ophthalmology on 30 October 2018 in Chicago, IL.

    • Collaborators The following is a list of the members of the TREX-DME Study Group and each were responsible for study protocol administration: Palmetto Retina Center: John F Payne, MD (Chair); W Lloyd Clark, MD; John A Wells, III, MD; David L Johnson, MD; Retina Consultants of Houston: Charles C Wykoff, MD; David M Brown, MD; Matthew Benz, MD; Eric Chen, MD; Richard H Fish, MD; Rosa Y Kim, MD; James C Major, Jr., MD; Ronan E O’Malley, MD; Amy C Schefler, MD; Ankoor R Shah, MD; Tien P Wong, MD; Retina-Vitreous Associates Medical Group: David S Boyer, MD; Roger L Novack, MD; Thomas G Chu, MD; Firas Rahhal, MD; Homayoun Tabandeh, MD; Richard H Roe, MD; Pouya N Dayani, MD; David Liao, MD; Alexander Walsh, MD; Daniel D Esmaili, MD.

    • Contributors JP: Responsible for study design, protocol writing and administration, adverse event monitoring, acquisition and analysis of statistical data, as well as drafting and revising manuscript. CCW: Responsible for study design, protocol writing and administration, acquisition and analysis of statistical data, as well as drafting and revising manuscript. WLC: Responsible for study design, protocol writing and administration, acquisition and analysis of statistical data, as well as drafting and revising manuscript. BB: Responsible for study design, acquisition and analysis of statistical data, as well as drafting and revising manuscript. DSB: Responsible for study design, protocol writing and administration, acquisition and analysis of statistical data, as well as drafting and revising manuscript. DB: Responsible for study design, protocol writing and administration, acquisition and analysis of statistical data, as well as drafting and revising manuscript.

    • Funding Research grant from Genentech (ML28724).

    • Disclaimer The funding organisation had no role in the design or conduct of this research.

    • Competing interests JP: Received research grant funding for TREX-DME from Genentech. Has also received research grant funding from Genentech, Regeneron and the Diabetic Retinopathy Clinical Research Network. CCW: Received personal fees from Acucela, Aerpio, Alimera, Allegro, Allergan, Apellis, Bayer, Chengdu Kanghong, Clearside Biomedical, DORC, Eyepoint, Genentech/Roche, Iveric Bio, Kodiak, Novartis, ONL Therapeutics, Outlook Therapeutics, Oxurion, PolyPhotonics, Recens Medical, Regeneron, Regenxbio, Santen and Takeda. Received research grant funding from Adverum, Aerie Pharmaceuticals, Aerpio, Allergan, Apellis, Chengdu Kanghong, Clearside Biomedical, Gemini Therapeutics, Genentech/Roche, Graybug Vision, IONIS Pharmaceuticals, Iveric Bio, Kodiak, Neurotech, Novartis, Ophthea, Outlook Therapeutics, Recens Medical, Regeneron, Regenxbio, Samsung, Santen and Xbrane Biopharma. WLC: Received personal fees from Regeneron, Genentech, Diabetic Retinopathy Clinical Research Network, Thrombogenics and Ophthea. BB: Received personal fees from Genentech, Emory University, Bayer, Medimmune and individual litigants. DSB: Received personal fees from Alcon, Allegro, Allergan, Bayer, Chengdu Kanghong and Regeneron. DB: Received personal fees from Novartis, Regeneron, Bayer, Genentech/Roche, Adverum, Kodiak, Senju, Chengdu Kanghong, Boehringer Ingelheim, Allegro, Apellis, Gemini, Regenxbio, Stealth, Santen, Heidelberg, Optos, Navilas, Ocular Therapeutics, iRenix and Lineage Cell. Received research grant funding from Novartis, Regeneron, Bayer, Genentech/Roche, Adverum, Kodiak, Senju, Chengdu Kanghong, Boehringer Ingelheim, Allegro, Apellis, Gemini, Regenxbio, Stealth, Santen, Heidelberg, Optos, Navilas, NEI, NGM, Ionis, Outlook Therapeutics, Xbrane Biopharma and Graybug Vision.

    • Patient consent for publication Not required.

    • Ethics approval A centralised institutional review board (Sterling IRB) approved all study protocols and procedures.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request.

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