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

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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

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Contacts and Locations
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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
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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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