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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03374670
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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

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


Contacts
Contact: Natasha Malik 917-753-9399 natasha.malik@ophthotech.com

Locations
United States, Hawaii
Retina Consultants of Hawaii Recruiting
'Aiea, Hawaii, United States, 96701
Sponsors and Collaborators
Ophthotech Corporation

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT03374670     History of Changes
Other Study ID Numbers: OPH2006
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ophthotech Corporation:
Zimura
ARC1905
Eylea
aflibercept
IPCV
avacincaptad pegol
complement factor C5 inhibitor

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases