Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

Phase 3 Completed 321 enrolled Novartis

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Timeline

Start: 2007-02
Primary completion: 2009-10
Completion: 2009-10

Outcome

Missed primary endpoint

paper Noninferiority of either combination regimen to monthly ranibizumab monotherapy was not demonstrated (primary end point). PMID 22444829 ↗

Publications

Kaiser PK, Boyer DS, Cruess AF, Slakter JS, Pilz S, Weisberger A; DENALI Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month results of the DENALI study. Ophthalmology. 2012 May;119(5):1001-10. doi: 10.1016/j.ophtha.2012.02.003. Epub 2012 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal
Subject	Verteporfin	Other / unclassified	6 mg/m2	Intravenous