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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943072
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Macular Edema Secondary to Central Retinal Vein Occlusion Biological: VEGF Trap-Eye 2.0mg Drug: Sham Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and at Week 24 ]
  3. 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 ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943072


Locations
Hide Hide 61 study locations
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United States, Arizona
Phoenix, Arizona, United States, 85014
Phoenix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
United States, 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
United States, Connecticut
New London, Connecticut, United States, 06320
United States, 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
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Maryland
Baltimore, Maryland, United States, 21209
Hagerstown, Maryland, United States, 21740
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Grand Rapids, Michigan, United States, 49525
Jackson, Michigan, United States, 48104
United States, Nebraska
Lincoln, Nebraska, United States, 68506
United States, Nevada
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Northfield, New Jersey, United States, 08225
Toms River, New Jersey, United States, 08755
United States, New York
Rochester, New York, United States, 14620
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Portland, Oregon, United States, 97210
Salem, Oregon, United States, 97302
United States, Pennsylvania
Kingston, Pennsylvania, United States, 18704
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Abilene, Texas, United States, 79606
Ft Worth, Texas, United States, 76102
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78240
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Victoria, British Columbia, Canada, V8V 4X3
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London, Ontario, Canada, N6A 4V2
Mississauga, Ontario, Canada, L4W 1W9
Toronto, Ontario, Canada, M4N 3M5
Colombia
Medellin, Antioquia, Colombia
Bogota, Colombia
India
Hyderabad, A.p., India, 500034
Bangalore, Karnataka, India, 560010
Kolkata, West Bengal, India, 700073
Israel
Kfar-Saba, Israel, 44281
Petah Tikva, Israel, 49100
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00943072    
Other Study ID Numbers: VGFT-OD-0819
First Posted: July 21, 2009    Key Record Dates
Results First Posted: May 27, 2013
Last Update Posted: May 27, 2013
Last Verified: April 2013
Keywords provided by Regeneron Pharmaceuticals:
Macular edema
Retinal vein occlusion
CRVO
VEGF Trap-Eye
best-corrected visual acuity
Regeneron
COPERNICUS
Additional relevant MeSH terms:
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Neoplasm Metastasis
Macular Edema
Retinal Vein Occlusion
Edema
Neoplastic Processes
Neoplasms
Pathologic Processes
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents