Combination therapy may be beneficial in some AMD patients to reduce treatment burden

There were visual gains with ranibizumab monotherapy and combination therapy with verteporfin photodynamic therapy in the treatment of choroidal neovascularization secondary to age-related macular degeneration. However, combination regimens did not demonstrate noninferiority, a study found.

“Combination therapy with verteporfin PDT and ranibizumab may have a role in some patients in the treatment of neovascular AMD because the potential remains for such combination therapy to reduce the overall treatment burden,” the study authors wrote.

The DENALI study, a prospective, randomized, double-masked, multicenter phase 3b clinical trial, included 286 patients at final follow-up of 12 months. Patients received either 0.5 mg Lucentis (ranibizumab, Genentech) monthly or standard fluence or reduced fluence verteporfin PDT combination therapy. The two combination groups were given three consecutive monthly injections of ranibizumab, followed by monthly monitoring and re-treatment as needed.

For the 91 patients in the verteporfin standard fluence group and the 93 patients in the verteporfin reduced fluence group, best corrected visual acuity improved by 5.3 and 4.4 letters, respectively, at 12 months. However, the 102 patients who received ranibizumab monotherapy gained 8.1 letters, meaning that the study’s primary endpoint of noninferiority for the combination regimens was not achieved.

The verteporfin standard fluence and reduced fluence groups required a mean of 5.1 and 5.7 ranibizumab injections, respectively, while the ranibizumab monotherapy group received a mean of 10.5 injections.

Safety and tolerability of all regimens were consistent with prior studies.