Idiopathic Polypoidal Choroidal Vasculopathy
Conditions
Keywords
Zimura, ARC1905, Eylea, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor
Brief summary
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
Interventions
DRUGZimura
Zimura in combination with Eylea
DRUGEylea
Zimura in combination with Eylea
Sponsors
Ophthotech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | 9 months | AEs |
Countries
United States
Outcome results
None listed