September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Prospective Trial Comparing Ranibizumab Monthly to Treat & Extend With & Without Angiography-Guided Laser for DME: TREX-DME 1 Year Outcomes
Author Affiliations & Notes
  • John Payne
    Palmetto Retina Center, West Columbia, South Carolina, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Houston, Texas, United States
  • W. Lloyd Clark
    Palmetto Retina Center, West Columbia, South Carolina, United States
  • Beau B Bruce
    Ophthalmology, Emory University, Atlanta, Georgia, United States
  • David M Brown
    Retina Consultants of Houston, Houston, Texas, United States
  • David S Boyer
    Retina-Vitreous Associates Medical Group, Los Angeles, California, United States
  • Footnotes
    Commercial Relationships   John Payne, Alcon (F), DRCR.Network (F), Genentech (F), Regeneron (F); Charles Wykoff, Alcon (C), Alcon/Novartis (F), Alimera (C), Allegro Ophthalmic (F), Allergan (C), Allergan (S), Allergan (F), Apellis Pharmaceuticals (F), Bayer (C), DRCR.Network (F), Genentech (C), Genentech/Roche (F), Iconic Therapeutics (F), Regeneron (C), Regeneron (S), Regeneron/Bayer (F), Roche (C), Thrombogenics (C), Valeant Pharmaceuticals (C); W. Clark, Allergan (F), Bayer (C), Genentech (C), Genentech/Roche (F), OD-OS (F), Regeneron (F), Regeneron (C), Santen (F), Santen (C); Beau Bruce, None; David Brown, Alcon (C), Alimera (C), Allergan (C), Avalanche (C), Bayer (C), Bayer (F), Clearside (C), Genentech/Roche (C), Genentech/Roche (F), Heidelberg (C), NEI (F), Novartis (C), Novartis (F), Ophthotech (C), Optos (C), Regeneron (C), Regeneron (F), Stealth Peptides (C), Thrombogenics (C), Zeiss (C); David Boyer, Aerpio (C), Aerpio (F), Alcon (C), Allegro (C), Allergan (C), Allergan (F), Bayer (C), Genentech (C), Genentech (F), Kalvista (F), Navilas (C), Navilas (F), Novartis (C), OHR (C), OHR (F), Regeneron (C), Regeneron (F), River Vision (C), River Vision (F), Santen (C)
  • Footnotes
    Support  Investigator-Sponsored Trial with support from Genentech
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      John Payne, Charles Clifton Wykoff, W. Lloyd Clark, Beau B Bruce, David M Brown, David S Boyer; Prospective Trial Comparing Ranibizumab Monthly to Treat & Extend With & Without Angiography-Guided Laser for DME: TREX-DME 1 Year Outcomes. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To compare monthly dosing to a treat & extend algorithm using 0.3 mg ranibizumab with and without angiography-guided laser photocoagulation for center-involving diabetic macular edema (DME).

Methods : This is a multicenter, prospective, randomized clinical trial of 150 eyes randomized 1:2:2 into three cohorts: Monthly (n=30), TReat & EXtend without macular laser photocoagulation (TREX; n=60), and treat & extend with angiography-GuIded LAser photocoagulation (GILA; n=60). Eyes in the TREX and GILA cohorts underwent 4 monthly injections of ranibizumab followed by a treat & extend algorithm based on disease activity. Those in the GILA cohort also received angiography-guided laser photocoagulation at month 1 and again every 3 months if microaneurysm leakage was present.

Results : Baseline demographics and markers of disease severity including duration of diabetes, insulin usage, body-mass index, severity of diabetic retinopathy, best corrected visual acuity (BCVA), and central retinal thickness (CRT) were well balanced between the three cohorts. 136 eyes (91%) completed the 1 year end-point visit. At 1 year, the BCVA improved 8.6, 9.6, 9.3 letters in the Monthly, TREX and GILA cohorts, respectively (p=0.8). Likewise, CRT by spectral-domain optical coherence tomography improved by 122, 146 and 165 µm, in the Monthly, TREX, GILA cohorts, respectively (p=0.47). The mean number of laser treatments in the GILA cohort at 1 year was 2.8 (range=1-4). Treatment burden, defined as the number of injections through 1 year, was significantly reduced in TREX (10.7) and GILA (10.2) compared to the Monthly cohort (13.1, p<0.001). Furthermore, there was a trend towards statistical significance in the mean maximum interval at month 12 for the TREX and GILA cohorts (8.1 versus 9.1 weeks, respectively; p=0.105). There were no cases of endophthalmitis, and the total incidence of nonfatal myocardial infarctions/cerebrovascular accidents, and deaths from vascular/unknown causes was 3.3%.

Conclusions : In this prospective, randomized trial involving 150 eyes, treat & extend dosing of ranibizumab with and without angiography-guided laser photocoagulation significantly decreased treatment burden while providing similar visual and anatomic outcomes compared to monthly dosing at 1 year.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Figure 1: LOESS regression analysis demonstrates longer treatment interval for the TREX/GILA cohorts.

Figure 1: LOESS regression analysis demonstrates longer treatment interval for the TREX/GILA cohorts.

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