ZIMURA in Combination With Eylea in Patients With Idiopat... | NCT03374670

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

NCT03374670

Sponsor

Ophthotech Corporation

Status

Withdrawn

Last Update Posted

Feb 21, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Idiopathic Polypoidal Choroidal Vasculopathy

Interventions

Zimura
Eylea

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients were enrolled. Study terminated for portfolio reasons.

Expanded Access Info

Start Date

Nov 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 11, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	Zimura dosage 1 + Eylea 2 mg	Drug: Zimura Drug: Eylea
Cohort 2	Experimental	Zimura dosage 2 + Eylea 2 mg	Drug: Zimura Drug: Eylea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zimura	Drug	Zimura in combination with Eylea	Cohort 1 Cohort 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs)	AEs	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Consultants of Hawaii		‘Aiea	Hawaii	96701	United States

Condition Browse Module

MeSH Terms

ID	Term
D000092342	Polypoidal Choroidal Vasculopathy

Ancestor Terms

ID	Term
D020256	Choroidal Neovascularization
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C533178	aflibercept

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided