Research Title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Robert Stoltz, M.D., Ph.D.
Description: Following a 4-week maximum screening period, patients will be randomized and treated for approximately 76 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects will enter a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an active or a sham injection. Treatment with active will be interrupted when disease stability is reached. Maximum study duration per patient is 80 weeks.
Start Date: October 2019
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC, COA; Stephanie Campbell, CRC, COA; Amber Adams, CRC, COA
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060