NCT02397954

Brief Summary

The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 19, 2015

Results QC Date

January 2, 2019

Last Update Submit

March 11, 2025

Conditions

Idiopathic Polypoidal Choroidal Vasculopathy

Keywords

idiopathic polypoidal choroidal vasculopathyIPCVZimura™ (previous name)Avastin®Eylea®Lucentis®

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With >15 ETDRS Letter Loss at Month 3

    Number of participants with \>15 ETDRS letter loss (with calculated percentage)

    3 Months

  • Number of Participants With Ophthalmic Adverse Events

    Number of Participants with Ophthalmic Adverse Events (with calculated percentage)

    3 months

  • Number of Participants With Systemic Adverse Events

    Number of Participants with Systemic Adverse Events (with calculated percentage)

    3 months

Other Outcomes (2)

  • Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3

    Baseline and Month 3

  • Regression and/or Elimination of Polyps at Month 3

    Baseline and Month 3

Study Arms (1)

Avacincaptad Pegol + Anti-VEGF

EXPERIMENTAL

Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea.

Drug: Avacincaptad Pegol

Interventions

Avacincaptad PegolDRUG

Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.

Also known as: Zimura (previous name), IZERVAY, Avastin, Eylea, Lucentis, ARC1905
Avacincaptad Pegol + Anti-VEGF

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of either gender aged ≥ 50 years
  • Diagnosis of IPCV
  • Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months

You may not qualify if:

  • Any intraocular surgery or thermal laser within three (3) months of trial entry
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection in the twelve (12) weeks prior to entry
  • History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
  • Previous therapeutic radiation in the region of the study eye
  • A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85014, United States

Location

Related Publications (1)

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

    PMID: 30957581DERIVED

Related Links

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

BevacizumabafliberceptRanibizumab

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Keith Westby
Organization
Ophthotech Corp
Keith.Westby@ophthotech.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 25, 2015

Study Start

March 12, 2015

Primary Completion

October 23, 2015

Study Completion

October 23, 2015

Last Updated

March 20, 2025

Results First Posted

January 23, 2019

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

US(1)