A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

October 19, 2024 updated by: Ophthotech Corporation
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

  • Avastin® 1.25 mg/eye (20 subjects)
  • Lucentis® 0.5 mg/eye (20 subjects)
  • Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Study Type

Interventional

Enrollment (Actual)

63

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
    • California
      • Beverly Hills, California, United States, 90211
      • Sacramento, California, United States, 95819
      • Santa Ana, California, United States, 92705
    • Connecticut
      • New London, Connecticut, United States, 06320
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Myers, Florida, United States, 33912
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Oak Forest, Illinois, United States, 60452
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Southfield, Michigan, United States, 48034
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
    • Nevada
      • Reno, Nevada, United States, 89502
    • New York
      • Rochester, New York, United States, 14620
    • Ohio
      • Cleveland, Ohio, United States, 44130
    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, United States, 19006
    • South Carolina
      • Ladson, South Carolina, United States, 29456
    • Texas
      • Abilene, Texas, United States, 85014
      • Amarillo, Texas, United States, 79106
      • San Antonio, Texas, United States, 78240
      • The Woodlands, Texas, United States, 77384
    • Washington
      • Silverdale, Washington, United States, 98383
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

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.
  • Active subfoveal choroidal neovascularization (CNV) due to AMD.

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.
  • Subjects with subfoveal scar or subfoveal atrophy
  • Any ocular or periocular infection in the past twelve (12) weeks.
  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fovista® plus bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Drug: bevacizumab
Other Names:
  • Avastin®
Drug: Fovista®
Experimental: Fovista® plus ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Drug: ranibizumab
Other Names:
  • Lucentis®
Drug: Fovista®
Experimental: Fovista® plus aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Drug: aflibercept
Other Names:
  • Eylea®
Drug: Fovista®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Numer of Systemic Adverse Events
Time Frame: 2 years
Number of Patients with Systemic Adverse Events
2 years
Total Number of Other Adverse Events (>5%)
Time Frame: 2 years
Number of Patients with Other Adverse Events
2 years

Collaborators and Investigators

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

Sponsor

Ophthotech Corporation

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 (Actual)

April 26, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimated)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 19, 2024

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

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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