A Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RC28-E 2mg Versus Aflibercept in Subjects With Wet Age-Related Macular Degeneration
This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.
• Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
• 50 years of age or older;
• Diagnosed with wAMD;
• Active CNV lesion of any type (ie, predominantly classic, minimally classic, or occult \[including polypoidal choroidal vasculopathy and retinal angiomatous proliferation\]) that exhibits all of the following characteristics:
‣ The CNV or sequela of the CNV affect the foveal;
⁃ A total lesion size of ≤12 disc areas on FFA;
⁃ Evidence of CNV leakage on FFA;
⁃ Intra and/or subretinal fluid confirmed on OCT;
• BCVA of 78-19 letters using the ETDRS protocol;
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis.