Results from two years of follow-up in a prospective, randomized clinical trial support the use of a treat-and-extend (TAE) regimen for managing diabetic macular edema (DME).
The investigator-initiated study, known as TREX-DME, found that anatomic and functional benefits were similar among patients receiving TAE ranibizumab (Lucentis, Genentech) with or without guided focal laser compared with controls getting anti-VEGF injections on a fixed monthly schedule.
The treatment burden, however, was reduced significantly with the TAE approach, although adjuvant treatment with focal laser did not provide any statistically significant benefit for improving outcomes or reducing injection burden compared with TAE ranibizumab alone, said David M. Brown, MD.
“The RISE and RIDE studies with ranibizumab were the first DME studies to demonstrate robust vision gains and maintenance of the benefits with monthly anti-VEGF therapy compared to standard of care with focal laser,” explained Dr. Brown. “When applying the findings to clinical practice, however, two important questions remained. First, can the same outcomes be achieved with less-frequent therapy, such as with a TAE protocol that is often used in the clinic, and is there benefit from adding laser to the anti-VEGF therapy?”
Dr. Brown is in private practice and clinical research coordinator, Greater Houston Retina Research, Retina Consultants of Houston, TX.
“The TREX-DME trial was designed to answer those questions,” Dr. Brown outlined. “The overall results show that DME can be safely and effectively managed with a treat-and-extend regimen with or without adjunct guided laser. While on average at 2 years, adjunct laser did not provide additional benefit, ongoing 3-year results and subgroup analyses are being performed to determine which patients might benefit from guided laser closure of micro-aneurysms.”