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Novartis announces trial of Visudyne-Lucentis combination treatment
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EAST HANOVER, N.J. — Novartis Pharmaceuticals Corp. will conduct a randomized, controlled, multicenter clinical trial evaluating combined treatment with verteporfin photodynamic therapy and ranibizumab, the company announced.
The study will gauge the safety, efficacy and impact on re-treatment rates of Visudyne (verteporfin for injection, Novartis) and Lucentis (ranibizumab, Genentech) as a combination therapy against wet age-related macular degeneration, according to a Novartis press release.
The trial, called DENALI, will include 300 wet AMD patients at 45 centers in the United States and five centers in Canada. The 2-year study will investigate whether patients receiving the combination therapy require fewer re-treatments than control patients treated with Lucentis monotherapy, according to the release.
The DENALI trial is part of Novartis' SUMMIT Trial Program, which includes a European companion trial called MONT BLANC scheduled to begin in several months. However, "While the results of the DENALI trial will be important for the study and development of future treatment paradigms in wet AMD, these results are not currently intended to support additional indications for Visudyne," company officials noted in the release.
"Novartis will assess data generated from DENALI as they become available to determine the most appropriate use of the results," they said.