Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)

March 10, 2015 updated by: Regeneron Pharmaceuticals

An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration

The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 3

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Mississauga, Ontario, Canada
      • Ottawa, Ontario, Canada
    • Quebec
      • Montreal (2 locations), Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • United States
    • Alabama
      • Birmingham (2 locations), Alabama, United States
    • Arizona
      • Phoenix (2 locations), Arizona, United States
      • Tucson (2 locations), Arizona, United States
    • California
      • Arcadia, California, United States
      • Beverly Hills, California, United States
      • Campbell, California, United States
      • Fresno, California, United States
      • Fullerton, California, United States
      • La Jolla, California, United States
      • Loma Linda, California, United States
      • Mountain View, California, United States
      • Oakland, California, United States
      • Orange, California, United States
      • Palm Desert, California, United States
      • Sacramento, California, United States
      • San Mateo, California, United States
      • Santa Ana, California, United States
      • Torrance, California, United States
      • Westlake Village, California, United States
      • Yorba Linda, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Denver (2 Locations), Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • New Haven, Connecticut, United States
      • New London, Connecticut, United States
    • Florida
      • Altamonte Springs, Florida, United States
      • Boynton Beach, Florida, United States
      • Fort Myers (2 locations), Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando (2 locations), Florida, United States
      • Oscala, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • Pensacola, Florida, United States
      • Stuart, Florida, United States
      • Tampa, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Hawaii
      • Aiea, Hawaii, United States
    • Illinois
      • Glenview, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Indianapolis, Indiana, United States
      • New Albany, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
      • Portland, Maine, United States
    • Maryland
      • Baltimore (3 Locations), Maryland, United States
      • Chevy Chase, Maryland, United States
      • Hagerstown, Maryland, United States
    • Massachusetts
      • Boston (2 Locations), Massachusetts, United States
      • Peabody, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Battle Creek, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Jackson, Michigan, United States
      • Southfield, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Florissant, Missouri, United States
      • Kansas City, Missouri, United States
      • Springfield, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Missoula, Montana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Lawrenceville, New Jersey, United States
      • Northfield, New Jersey, United States
      • Toms River, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Brooklyn, New York, United States
      • Lynbrook, New York, United States
      • New York (6 locations), New York, United States
      • Rochester (2 locations), New York, United States
      • Slingerlands, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Ashland, Oregon, United States
      • Portland (3 Locations), Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States
      • Philadelphia (3 locations), Pennsylvania, United States
      • Pittsburgh (2 locations), Pennsylvania, United States
      • West Mifflin, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • West Columbia, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin (3 Locations), Texas, United States
      • Dallas, Texas, United States
      • Fort Worth (2 locations), Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
      • Odessa, Texas, United States
      • San Antonio (2 locations), Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City (2 locations), Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Fairfax, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Madison (2 Locations), Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participation in Study VGFT-OD-0605 through week 96.
  • In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

Exclusion Criteria:

  • Presence of any condition that would jeopardize the patient's participation in this study.
  • Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.

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: Open-label Intravitreal Aflibercept Injection
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Drug: Intravitreal Aflibercept Injection 2mg
Other Names:
  • IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Time Frame: Baseline (day 1) through end of treatment (Week 180)

The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).

Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Baseline (day 1) through end of treatment (Week 180)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BCVA Letter Score (mLOCF)
Time Frame: Baseline through Week 116

The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.

(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).
Baseline through Week 116

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Treatment Duration (Weeks)
Time Frame: Baseline through end of treatment (Week 180)
Treatment Duration = (last dose date - first dose date + 28)/7
Baseline through end of treatment (Week 180)
Summary of Study Duration (Weeks)
Time Frame: Baseline through end of treatment (Week 180)
Study Duration = (last visit/ discontinuation date - first dose date + 28)/7
Baseline through end of treatment (Week 180)

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

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

December 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFT-OD-0910

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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