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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00943072
First received: July 10, 2009
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Edema
Drug Information available for: Aflibercept
U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy measure is improvement in visual acuity versus baseline after 6 months of treatment. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Retinal thickness by OCT [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943072

  Show 61 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00943072     History of Changes
Other Study ID Numbers: VGFT-OD-0819
Study First Received: July 10, 2009
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Canada: Health Canada
Israel: Ministry of Health
Colombia: Institutional Review Board

Keywords provided by Regeneron Pharmaceuticals:
Macular edema
Retinal vein occlusion
CRVO
VEGF Trap-Eye
 best-corrected visual acuity
Regeneron
COPERNICUS

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013