TREX-AMD trial finds visual gains from treat-and-extend vs. monthly
Take-home: Treat-and-extend approach for neovascular AMD leads to beneficial results in 2-year clinical trial.
A study using a treat-and-extend approach for wet age-related macular degeneration (AMD) found similar outcomes for both monthly and treat-and-extend patients over 2 years.
The goal of the treat-and-extend approach was to individualize ranibizumab (Lucentis, Genentech) dosing while optimizing visual benefits, said Dr. Wykoff, who is in private practice in Houston. This is in contrast to planned monthly doses of the anti-vascular endothelial growth factor (anti-VEGF) injections used in wet AMD patients.
“The goal is to maintain an exudation-free macula and avoid multiple disease recurrences as can occur with PRN dosing, while minimizing the treatment burden through fewer clinical visits, diagnostics, and treatments,” according to Dr. Wykoff’s presentation abstract.
The TREX-AMD—short for Treat and Extend Protocol in Patients with wet Age-Related Macular Degeneration—is a phase 3b multicenter trial that included 60 eyes that were not treated before and had a visual acuity of 20/32 to 20/500. Twenty eyes received monthly injections of ranibizumab, and 40 received treat-and-extend dosing.
In the latter group, the eyes were treated every 4 weeks for a minimum of 3 injections until a dry macula was achieved. At that point, treatment was lengthened by 2-week intervals, until a maximum of 12 weeks.
“Once stability was achieved, the maximum extension interval was rechallenged, using a rigid prospective protocol,” Dr. Wykoff added.
Investigators used spectral domain optical coherence tomography (SD-OCT) to check for intraretinal and subretinal fluid and ophthalmoscopy to check for hemorrhage.