Clincosm LogoSign in Get a demo

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

Sponsor
Ophthotech Corporation (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03374670
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Zimura dosage 1 + Eylea 2 mg

Drug: Zimura
Zimura in combination with Eylea
Other Names:
  • avacincaptad pegol

    • Drug: Eylea
    Zimura in combination with Eylea
    Other Names:
  • aflibercept

    		•
    Experimental: Cohort 2

    Zimura dosage 2 + Eylea 2 mg

    Drug: Zimura
    Zimura in combination with Eylea
    Other Names:
  • avacincaptad pegol

    • Drug: Eylea
    Zimura in combination with Eylea
    Other Names:
  • aflibercept

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (AEs) [9 months]

      AEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701

    Sponsors and Collaborators

    • Ophthotech Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ophthotech Corporation
    ClinicalTrials.gov Identifier:
    NCT03374670
    Other Study ID Numbers:
    • OPH2006
    First Posted:
    Dec 15, 2017
    Last Update Posted:
    Jan 18, 2019
    Last Verified:
    Sep 1, 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
    Aflibercept

    Study Results

    No Results Posted as of Jan 18, 2019