Novartis Pharmaceuticals began studying its DENALI trial, to explore combining injectable verteporfin (Visudyne; Novartis, East Hanover, NJ) and ranibizumab (Lucentis: Genetech, San Francisco, CA) for the treatment of age-related macular degeneration (AMD). The study will compare the ranizumab combination therapy with ranizumab monotherapy in patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD, according to a news release.

“The rationale behind this trial is based on the potential to improve outcomes and reduce the frequency of treatments by combining therapies that target AMD with different mechanisms of action,” said lead investigator, Peter Kaiser, MD, Division of Ophthalmology, Cleveland Clinic Cole Eye Institute. “The DENALI trial could be an important step in helping understand multifactorial treatment of wet AMD.” Dr. Kaiser is a member of the Retina Today editorial board.

Approximately 300 patients, aged >50 years old with primary or active CNV secondary to AMD, will be enrolled in the 2-year study. The trial will evaluate whether patients with combination therapy need fewer treatments than those receiving ranibizumab monotherapy. The study’s primary endpoints will measure BCVA at month 12 using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol and the proportion of patients with a treatment free interval of at least 3 months. Secondary endpoints will evaluate the treatment burden of Visudyne combination therapy, including the number of retreatments following the month 2 treatments, and the time to first retreatment.

The DENALI trial is part of the SUMMIT Trial Program, which also includes a companion trial—MONT BLANC—scheduled to begin in the coming months in Europe. 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. Novartis will assess data generated from DENALI, as they become available, to determine the most appropriate use of the results.

Verteporfin for injection is the first drug therapy approved by the US Food and Drug Administration for the treatment of AMD in patients with predominantly classic subfoveal CNV. Verteporfin is also indicated for treatment of pathologic myopia or presumed ocular histoplasmosis. When activated by light, it causes local damage to the neovascular endothelium in the macula, resulting in vessel occlusion. Visudyne photodynamic therapy slows or stops progression of neovascular AMD, according to company literature.

“Visudyne continues to play an important role in wet AMD treatment, and through the DENALI trial we are exploring its role in future treatment strategies,” said Marion Morton, head of the US Ophthalmics Business Unit for Novartis. “Novartis is committed to supporting and publishing robust, clinical data needed to advance treatment paradigms in the rapidly evolving AMD marketplace.”