Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374670
Recruitment Status : Withdrawn (No patients were enrolled. Study terminated for portfolio reasons.)
First Posted : December 15, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ophthotech ( Ophthotech Corporation )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Idiopathic Polypoidal Choroidal Vasculopathy Drug: Zimura Drug: Eylea Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort 1
Zimura dosage 1 + Eylea 2 mg
 Drug: Zimura
Zimura in combination with Eylea
Other Name: avacincaptad pegol

Drug: Eylea
Zimura in combination with Eylea
Other Name: aflibercept
Experimental: Cohort 2
Zimura dosage 2 + Eylea 2 mg
 Drug: Zimura
Zimura in combination with Eylea
Other Name: avacincaptad pegol

Drug: Eylea
Zimura in combination with Eylea
Other Name: aflibercept


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 9 months ]
    AEs


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374670


Locations
Layout table for location information
United States, Hawaii
Retina Consultants of Hawaii
'Aiea, Hawaii, United States, 96701
Sponsors and Collaborators
Ophthotech Corporation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT03374670    
Other Study ID Numbers: OPH2006
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ophthotech ( Ophthotech Corporation ):
Zimura
ARC1905
Eylea
aflibercept
 IPCV
avacincaptad pegol
complement factor C5 inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Polypoidal Choroidal Vasculopathy
Vascular Diseases
Cardiovascular Diseases
Choroidal Neovascularization
Choroid Diseases
Uveal Diseases
Eye Diseases
Neovascularization, Pathologic
Metaplasia
 Pathologic Processes
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents