RHONE-X trial evaluates extended dosing in DME patients

Matt Star, MD, assistant professor of ophthalmology and the Program Director of the residence program at the Mayo Clinic, discusses the RHONE-X trial. RHONE-X is a long-term, multicentered, open-label extension trial of both the YOSEMITE and RHINE trials. It evaluated the use of a treat-and-extend dosing regimen of faricimab for the treatment of diabetic macular edema (DME).

"It is the first 4-year study of treat-and-extend dosing for patients receiving faricimab for diabetic macula edema," Starr said. "The highlights of that study showed that patients who received faricimab had a treat-and-extend dosing interval had maintained vision and central subfield thickness improvements that were seen in YOSEMITE and RHINE up to 4 years with a significantly fewer number of injections. The median number of faricimab injections in year 4 for all patients was only 3."

Starr said the take home message "is that using a treat-and-extend dosing with faricimab for patients with diabetic macula edema, many patients are able to extend it out to 12 weeks, 16 weeks, and still maintain vision and CST improvements over time."

The study followed nearly 1,500 eyes over 4 years, with an 82% retention rate. Key findings reveal that patients using faricimab maintained significant vision improvements, achieving a consistent 10-letter gain across different initial treatment arms.

"Patients in YOSEMITE and RHINE saw about a 10-letter gain at the end of those study periods, and by the end of RHONE-X, the same letter gain was achieved," he continued. "All patients had about a 10-letter gain at the end of RHONE-X, irregardless of the treatment arm in YOSEMITE and RHINE, whether it was Q8 week aflibercept, Q8 week faricimab, or the treat-and-extend faricimab from the beginning. And so once those patients were then transitioned from those treatment arms into a treat-and-extend regiment, they still maintained those 10-letter vision gains from baseline with about about a 200 micron reduction in CST from baseline as well."

The study's primary focus was on reducing treatment frequency without compromising clinical outcomes. By demonstrating that patients can maintain vision with fewer injections, the RHONE-X trial represents a significant advancement in DME management, potentially improving patient quality of life by minimizing clinic visits and treatment intensity.

Future research will continue through ad-hoc analyses of this dataset.