Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

February 20, 2024 updated by: Ophthotech Corporation

A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Study Type

Interventional

Enrollment (Actual)

101

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
      • Sacramento, California, United States, 95841
      • Santa Ana, California, United States, 92705
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Oak Forest, Illinois, United States, 60452
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Jackson, Michigan, United States, 49202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • South Carolina
      • Ladson, South Carolina, United States, 29456
    • Texas
      • Abilene, Texas, United States, 79606

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

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years
  • All fluorescein angiographic subtypes with presence of active choroidal neovascularization

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fovista® plus anti-VEGF Simultaneous
Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
Drug: Fovista® (anti-PDGF BB) plus anti-VEGF
Other Names:
  • Fovista®
  • anti-VEGF
Experimental: Fovista® plus anti-VEGF Pre-Treatment
Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
Drug: Fovista® (anti-PDGF BB) plus anti-VEGF
Other Names:
  • Fovista®
  • anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
Time Frame: 2 years
Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)
2 years
Number of Subjects With Serious Adverse Events
Time Frame: 2 years
Number of subjects with serious adverse events in each arm
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

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimated)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH1005

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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