Date: 2016-12-12
Type of information: Results
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: pegpleranib in combination with Lucentis® (ranibizumab)
Action mechanism:
Disease: neovascular age-related macular degeneration
Therapeutic area: Ophtalmological diseases
Country: Argentina, Australia, Austria, Belgium ,Brazil ,Canada, Colombia, Czech Republic, Estonia, Denmark, France, Germany, Hungary, Israel, Italy, Latvia, Poland, Slovakia, Spain, Switzerland, Turkey, UK, USA
Trial
details: The OPH1002 and OPH1003 studies are both randomized, double blind, Phase III clinical trial studies designed to evaluate the safety and efficacy of pegpleranib 1.5mg in combination with ranibizumab versus ranibizumab monotherapy in people with subfoveal neovascular age-related macular degeneration (nAMD). A total of 1,248 patients over the age of 50 were enrolled across both studies (621 patients in the OPH1002 study and 627 patients in the OPH1003 study)[6] and were randomized to receive either pegpleranib in combination with ranibizumab or ranibizumab alone each month up to the 12 month primary endpoint of the study. The primary efficacy endpoint in both studies was defined as mean change in best corrected visual acuity (BCVA) from baseline at 12 months. (NCT01944839, NCT01940900)
Latest
news: * On December 12, 2016, Novartis announced initial topline results from two pivotal Phase III clinical studies evaluating the safety and efficacy of pegpleranib in combination with Lucentis® (ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). Studies OPH1002 and OPH1003, sponsored by Ophthotech Corporation, did not meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy, measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy. At month 12, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement in study OPH1002 and a 9.91 letter BCVA improvement in study OPH1003. Patients treated with ranibizumab alone showed a 9.82 letter BCVA improvement in the OPH1002 study and a 10.36 letter BCVA improvement in the OPH1003 study. Data from the OPH1002 and OPH1003 studies, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting.
