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

Primary Purpose

Macular Edema Secondary to Central Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VEGF Trap-Eye 2.0mg
Sham
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema Secondary to Central Retinal Vein Occlusion focused on measuring Macular edema, Retinal vein occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity, Regeneron, COPERNICUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

VEGF Trap-Eye

Sham

Arm Description

Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint

Monthly Sham IVT injection until Week 24 Primary Endpoint

Outcomes

Primary Outcome Measures

Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
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.

Secondary Outcome Measures

Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
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.
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
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
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
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.

Full Information

First Posted
July 10, 2009
Last Updated
April 16, 2013
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00943072
Brief Title
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Secondary to Central Retinal Vein Occlusion
Keywords
Macular edema, Retinal vein occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity, Regeneron, COPERNICUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VEGF Trap-Eye
Arm Type
Experimental
Arm Description
Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Monthly Sham IVT injection until Week 24 Primary Endpoint
Intervention Type
Biological
Intervention Name(s)
VEGF Trap-Eye 2.0mg
Intervention Description
Monthly intravitreal injection out to the Week 24 Primary endpoint
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
Monthly sham intravitreal injection out to Week 24 Primary Endpoint
Primary Outcome Measure Information:
Title
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
Description
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.
Time Frame
Baseline and at Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline and at Week 24
Title
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Time Frame
Baseline and at Week 24
Title
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
Title
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
Description
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.
Time Frame
Baseline and at Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Ft Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4X3
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Medellin
State/Province
Antioquia
Country
Colombia
City
Bogota
Country
Colombia
City
Hyderabad
State/Province
A.p.
ZIP/Postal Code
500034
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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