Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Feb;105(2):253-257.
doi: 10.1136/bjophthalmol-2020-316176. Epub 2020 Apr 17.

Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results

John F Payne  1 , Charles C Wykoff  2 , W Lloyd Clark  3 , Beau B Bruce  4 , David S Boyer  5 , David M Brown  6 ; TREX-DME Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results

John F Payne et al. Br J Ophthalmol. 2021 Feb.

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.

Keywords: retina; treatment lasers; treatment medical.

PubMed Disclaimer

Conflict of interest statement

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.

Publication types

MeSH terms

Associated data