Combination therapy reduces re-treatment burden in wet AMD patients

VANCOUVER, British Columbia — Combination therapies generated greater visual acuity gains with fewer reinjections compared with monotherapy in a phase 2 study of patients with exudative age-related macular degeneration.

In the phase 2 RADICAL (Reduced fluence Visudyne anti-VEGF-dexamethasone in combination for AMD lesions) study, mean gain in visual acuity from baseline in 34 patients treated with half-fluence Visudyne (verteporfin photodynamic therapy, Novartis, QLT) of 300 mW/cm² for 83 seconds to deliver 25 J/cm², Lucentis (ranibizumab, Genentech) and dexamethasone was 2.0 letters of visual acuity at 24 months. Among 29 patients who received ranibizumab only, mean gain in visual acuity was 3.8 letters, but sample sizes may have been too small to detect significant changes, according to a press release announcing the results of the study.

A total of 35 patients treated with quarter-fluence burst Visudyne of 180 mW/cm² for 83 seconds to deliver 15 J/cm², ranibizumab and dexamethasone had a mean gain of 0.3 letters, while 33 patients who received half-fluence Visudyne and ranibizumab had a mean gain of 6.2 letters.

Although visual results were not significant, each combination therapy tested resulted in fewer re-treatments over 2 years compared with monotherapy: mean 4.2 re-treatments among the half-fluence triple therapy group, 5.8 re-treatments among the quarter-fluence triple therapy group, 6.2 re-treatments among the double therapy group and 8.9 re-treatments in the monotherapy group.

"Visudyne-Lucentis combination therapy significantly decreased the number of re-treatment visits required over 2 years, while patients' vision outcome was maintained within one line with an acceptable safety profile, compared with Lucentis alone," Henry Hudson, MD, one of the lead investigators in the study, said in the release.

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