Actively Recruiting // Central Retinal Vein Occlusion // Clinical Trials // Michael Altaweel // Retinal Vein Occlusion // Jun 12 2019
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: Michael Altaweel, MD
Study Coordinator: Angie Adler
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
This is a prospective, interventional multicenter study. 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.
Diagnosis and Key Eligibility Criteria:
Patients over the age of 18 with visual impairment (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits due to macular edema secondary to CRVO diagnosed < 6 months prior to screening. Patients cannot have had any previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline.
Duration of Study: 18 months
For more information, contact Angie Adler 608-265-7557