David M. brown
NEW ORLEANS — At 2 years, the TREX-DME trial demonstrated that adjuvant focal laser treatment provided no statistically significant anatomic benefit in patients treated with Lucentis, while a treat-and-extend protocol, with laser or without, did reduce treatment burden, David M. Brown, MD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting.
The objective of the trial was to compare monthly Lucentis (ranibizumab, Genentech) vs. treat-and-extend ranibizumab vs. guided laser plus treat-and-extend ranibizumab in patients with diabetic macular edema. Eyes were randomized 1:2:2, with 30 eyes receiving anti-VEGF only and 60 eyes on the treat-and-extend regimen with or without guided laser, a noncontact laser guided by fluorescein angiogram.
“The TREX-DME demonstrates that a treat-and-extend regimen with or without guided laser provides equivalent anatomic and visual acuity benefits with a significant reduction in treatment burden. However, at 2 years the adjuvant focal laser did not provide a statistically significant benefit,” he said.
Visual acuity gains were “robust,” Brown said: a mean change in ETDRS letters of 8.3 in the ranibizumab-only group, 11.4 in the treat-and-extend group and 10.5 in the group with guided laser, with no statistically significant difference among the groups. Patients gaining three lines were 24%, 27% and 30%, respectively.
“[There were] no three-line losers, exactly what you would expect. We got what we wanted,” Brown said.
Mean number of injections at week 104 was reduced from 24.7 in the monthly anti-VEGF-only group to 18.9 in the treat-and-extend group and 17.5 in the laser group (both P < .001).
Mean number of guided laser applications was 3.1 in year 1 and 1.9 in year 2. – by Patricia Nale, ELS
Brown DM. TREX DME trial: Two year outcomes. Presented at AAO Subspecialty Days; Nov. 10-11, 2017; New Orleans.
Disclosure: Brown reports he is a consultant and/or serves on the advisory boards for Adverum, Alcon/Novartis, Allegro, Allergan, Carl Zeiss Meditec, Coda Therapeutics, Clearside Biomedical, Envisia, Google Verily, Janssen, Johnson & Johnson, Genentech/Roche, which provided partial funding for the study, Heidelberg Engineering, Kanghong Pharma, Notal Vision, Ohr, Ophthotech, Optos/Nikon, Optovue, Pfizer, Regeneron/Bayer, Regenxbio, Samsung Bioepis, Santen, Senju Pharmaceutical, Stealth BioTherapeutics, ThromboGenics and Tyrogenex. OD-OS provided lasers for the study.