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

Primary Purpose

Idiopathic Polypoidal Choroidal Vasculopathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zimura
Eylea
Sponsored by
Ophthotech Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Polypoidal Choroidal Vasculopathy focused on measuring Zimura, ARC1905, Eylea, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Retina Consultants of Hawaii

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Zimura dosage 1 + Eylea 2 mg

Zimura dosage 2 + Eylea 2 mg

Outcomes

Primary Outcome Measures

Adverse Events (AEs)
AEs

Secondary Outcome Measures

Full Information

First Posted
December 11, 2017
Last Updated
January 16, 2019
Sponsor
Ophthotech Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03374670
Brief Title
ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were enrolled. Study terminated for portfolio reasons.
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation

4. Oversight

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

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Polypoidal Choroidal Vasculopathy
Keywords
Zimura, ARC1905, Eylea, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Zimura dosage 1 + Eylea 2 mg
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Zimura dosage 2 + Eylea 2 mg
Intervention Type
Drug
Intervention Name(s)
Zimura
Other Intervention Name(s)
avacincaptad pegol
Intervention Description
Zimura in combination with Eylea
Intervention Type
Drug
Intervention Name(s)
Eylea
Other Intervention Name(s)
aflibercept
Intervention Description
Zimura in combination with Eylea
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
AEs
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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