ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

Ophthotech

Status and phase: Withdrawn; Phase 2

Conditions: Idiopathic Polypoidal Choroidal Vasculopathy

Treatments: Drug: Zimura; Drug: Eylea

Study type: Interventional

Funder types: Industry

Identifiers

NCT03374670

OPH2006

Details and patient eligibility

About

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

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Zimura dosage 1 + Eylea 2 mg

Treatment:

Drug: Eylea

Drug: Zimura

Cohort 2

Experimental group

Description:

Zimura dosage 2 + Eylea 2 mg

Treatment:

Drug: Eylea

Drug: Zimura