A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

February 20, 2024 updated by: Ophthotech Corporation

A Phase 2a Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).

Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zimura + Anti-VEGF
Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea.
Drug: Zimura
Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Other Names:
  • Lucentis
  • Avastin
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With >15 ETDRS Letter Loss at Month 3
Time Frame: 3 Months
Number of participants with >15 ETDRS letter loss (with calculated percentage)
3 Months
Number of Participants With Ophthalmic Adverse Events
Time Frame: 3 months
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
3 months
Number of Participants With Systemic Adverse Events
Time Frame: 3 months
Number of Participants with Systemic Adverse Events (with calculated percentage)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3
Time Frame: Baseline and Month 3
Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT
Baseline and Month 3
Regression and/or Elimination of Polyps at Month 3
Time Frame: Baseline and Month 3
Regression and/or Elimination of Polyps from baseline to Month 3
Baseline and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthotech Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimated)

March 25, 2015

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data at this time

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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