A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy

OPH2006

To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy

2018-11-01

2019-12-01

2019-12-01

Withdrawn

Early phase I

Inclusion Criteria: * Diagnosis of IPCV * Patients must have had 3 sequential Eylea injections within the previous 4 months Exclusion Criteria: * Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea * History or evidence of severe cardiac disease * Any major surgical procedure within one month of trial entry * Subjects with a clinically significant laboratory value * Any treatment with an investigational agent in the past 60 days for any condition * Women who are pregnant or nursing * Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-02-21