Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

April 16, 2013 updated by: Regeneron Pharmaceuticals

A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

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
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
      • Victoria, British Columbia, Canada, V8V 4X3
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • London, Ontario, Canada, N6A 4V2
      • Mississauga, Ontario, Canada, L4W 1W9
      • Toronto, Ontario, Canada, M4N 3M5
  • Colombia
      • Bogota, Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
  • India
    • A.p.
      • Hyderabad, A.p., India, 500034
    • Karnataka
      • Bangalore, Karnataka, India, 560010
    • West Bengal
      • Kolkata, West Bengal, India, 700073
  • Israel
      • Kfar-Saba, Israel, 44281
      • Petah Tikva, Israel, 49100
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
      • Phoenix, Arizona, United States, 85014
      • Tucson, Arizona, United States, 85704
    • California
      • Arcadia, California, United States, 91007
      • Beverly Hills, California, United States, 90211
      • La Jolla, California, United States, 92037
      • Mountain View, California, United States, 94040
      • Oakland, California, United States, 94609
      • Sacramento, California, United States, 95841
      • Torrance, California, United States, 90503
    • Connecticut
      • New London, Connecticut, United States, 06320
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Fort Lauderdale, Florida, United States, 33334
      • Fort Myers, Florida, United States, 33907
      • Fort Myers, Florida, United States, 33912
      • Miami, Florida, United States, 33143
      • Palm Beach Gardens, Florida, United States, 33410
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Hagerstown, Maryland, United States, 21740
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
      • Jackson, Michigan, United States, 48104
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • Nevada
      • Las Vegas, Nevada, United States, 89135
    • New Jersey
      • Northfield, New Jersey, United States, 08225
      • Toms River, New Jersey, United States, 08755
    • New York
      • Rochester, New York, United States, 14620
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97210
      • Salem, Oregon, United States, 97302
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Abilene, Texas, United States, 79606
      • Ft Worth, Texas, United States, 76102
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78240

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
  • ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria:

  • Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
  • Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
  • CRVO disease duration > 9 months from date of diagnosis
  • Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
  • Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VEGF Trap-Eye
Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
Biological: VEGF Trap-Eye 2.0mg
Monthly intravitreal injection out to the Week 24 Primary endpoint
Sham Comparator: Sham
Monthly Sham IVT injection until Week 24 Primary Endpoint
Drug: Sham
Monthly sham intravitreal injection out to Week 24 Primary Endpoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
Time Frame: Baseline and at Week 24

Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Baseline and at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
Time Frame: Baseline and at Week 24
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Baseline and at Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Time Frame: Baseline and at Week 24
Baseline and at Week 24
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks
Time Frame: Baseline to Week 24
Baseline to Week 24
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
Time Frame: Baseline and at Week 24
The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Baseline and at Week 24

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

July 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFT-OD-0819

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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