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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

Tracking Information
First Submitted Date  ICMJE July 10, 2009
First Posted Date  ICMJE July 21, 2009
Results First Submitted Date  ICMJE October 19, 2012
Results First Posted Date  ICMJE May 27, 2013
Last Update Posted Date May 27, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
The primary efficacy measure is improvement in visual acuity versus baseline after 6 months of treatment. [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
  • 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.
  • Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
  • Visual acuity [ Time Frame: Week 24 ]
  • Retinal thickness by OCT [ Time Frame: Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Macular Edema Secondary to Central Retinal Vein Occlusion
Intervention  ICMJE
  • Biological: VEGF Trap-Eye 2.0mg
    Monthly intravitreal injection out to the Week 24 Primary endpoint
  • Drug: Sham
    Monthly sham intravitreal injection out to Week 24 Primary Endpoint
Study Arms  ICMJE
  • Experimental: VEGF Trap-Eye
    Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
    Intervention: Biological: VEGF Trap-Eye 2.0mg
  • Sham Comparator: Sham
    Monthly Sham IVT injection until Week 24 Primary Endpoint
    Intervention: Drug: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2011)
189
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2009)
165
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Colombia,   India,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00943072
Other Study ID Numbers  ICMJE VGFT-OD-0819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Robert Vitti, MD/Study Director, Regeneron Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP