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

Idiopathic Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03374670
• Other study ID #: OPH2006
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Polypoidal Choroidal Vasculopathy
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Zimura
Zimura in combination with Eylea
• Eylea
Zimura in combination with Eylea

Locations

Country	Name	City	State
United States	Retina Consultants of Hawaii	'Aiea	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Ophthotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	AEs	9 months