QLT reports 6-month results for trial of AMD combination therapy

VANCOUVER, British Columbia — An independent data and safety monitoring committee's review of 6-month interim data from a phase 2 study has found no safety concerns in the treatment groups and has recommended that the trial carry on as planned, QLT announced in a press release.

The randomized, multicenter, single-masked RADICAL study (Reduced fluence Visudyne anti-VEGF-dexamethasone in combination for AMD lesions) is comparing re-treatment rates and visual outcomes of three therapies. Reduced-fluence Visudyne (verteporfin, Novartis/QLT) and Lucentis (ranibizumab, Genentech) combination therapy, either with or without dexamethasone, and a ranibizumab monotherapy are being investigated among 162 patients with choroidal neovascularization due to age-related macular degeneration, the release said.

Specifically, patients were randomized to receive reduced-fluence verteporfin followed by ranibizumab, reduced-fluence verteporfin followed by ranibizumab and dexamethasone, very low-fluence verteporfin followed by ranibizumab and dexamethasone, or ranibizumab monotherapy administered for the first 2 months followed by injections on an as-needed basis.

At 6 months, each group had similar mean visual acuity letter score improvements from baseline. Cumulative re-treatment rates were lower in all combination groups compared with the monotherapy group, but the lower rates were influenced by mandatory re-treatments during the first 2 months in the monotherapy group, according to the release.

Consequently, a longer follow-up will be required to more accurately compare each group's elective re-treatment rates, the release said.

QLT expects to report 12-month primary endpoint results for the 24-month study in the first half of 2009.