ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Phase 2
Withdrawn
- Conditions
- Idiopathic Polypoidal Choroidal Vasculopathy
- Interventions
- Registration Number
- NCT03374670
- Lead Sponsor
- Ophthotech Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Zimura Zimura dosage 1 + Eylea 2 mg Cohort 1 Eylea Zimura dosage 1 + Eylea 2 mg Cohort 2 Zimura Zimura dosage 2 + Eylea 2 mg Cohort 2 Eylea Zimura dosage 2 + Eylea 2 mg
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) 9 months AEs
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of Zimura™ (anti-C5) in treating idiopathic polypoidal choroidal vasculopathy (IPCV)?
How does the combination of Zimura™ and Eylea® compare to standard anti-VEGF therapies for IPCV in terms of efficacy and safety?
Are there specific biomarkers for complement system activation that could predict response to Zimura™ in IPCV patients?
What are the potential adverse events associated with intravitreal administration of Zimura™ and Eylea® in IPCV treatment?
What other complement inhibitors or anti-VEGF combination therapies are being explored for choroidal vascular disorders like IPCV?
Trial Locations
- Locations (1)
Retina Consultants of Hawaii
🇺🇸'Aiea, Hawaii, United States
Retina Consultants of Hawaii🇺🇸'Aiea, Hawaii, United States