ranibizumab + sham injection

The entity referred to as 'ranibizumab + sham injection' represents the active control arm used in the Phase 3 clinical trial program (including studies OPH1002 and OPH1003) conducted by Ophthotech Corporation for the investigational drug Fovista (pegpleranib/E10030). This intervention consists of intravitreal injections of ranibizumab (Lucentis), a monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), administered in combination with a sham procedure. The sham component, often designated as 'E10030 sham' in trial documentation, involved applying pressure to the eye with a needleless syringe to mimic the administration of the investigational drug, thereby maintaining the double-masked nature of the study. This combination was used to compare the efficacy of anti-VEGF monotherapy against the combination of anti-VEGF and anti-PDGF (Fovista) therapy in patients with neovascular (wet) age-related macular degeneration. The Phase 3 program was ultimately terminated after the combination therapy failed to demonstrate a significant additional benefit over ranibizumab monotherapy.

Brand names

Lucentis

Other names

ranibizumab plus sham injectionLucentis plus sham