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DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact (DA VINCI)

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ClinicalTrials.gov Identifier: NCT00789477
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 7, 2008
First Posted Date  ICMJE November 11, 2008
Results First Submitted Date  ICMJE August 28, 2014
Results First Posted Date  ICMJE September 9, 2014
Last Update Posted Date September 9, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: At week 24 ]
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
Change in best corrected visual acuity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Change in BCVA From Baseline to Week 52 - LOCF [ Time Frame: At week 52 ]
    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
  • Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF [ Time Frame: At week 24 and week 52 ]
    Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
  • Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF [ Time Frame: At week 24 and week 52 ]
    Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
  • Number of Focal Laser Treatments [ Time Frame: Week 1 to week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
Change from baseline in foveal thickness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Official Title  ICMJE A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
Brief Summary This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
Detailed Description Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Procedure: Laser Photocoagulation
    laser every 16 weeks as needed
    Other Name: macular laser therapy
  • Drug: Intravitreal Aflibercept Injection
    Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
Study Arms  ICMJE
  • Experimental: Intravitreal Aflibercept Injection .5Q4
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
    Intervention: Drug: Intravitreal Aflibercept Injection
  • Experimental: Intravitreal Aflibercept Injection 2Q4
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
    Intervention: Drug: Intravitreal Aflibercept Injection
  • Experimental: Intravitreal Aflibercept Injection 2Q8
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
    Intervention: Drug: Intravitreal Aflibercept Injection
  • Experimental: Intravitreal Aflibercept Injection 2PRN
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
    Intervention: Drug: Intravitreal Aflibercept Injection
  • Active Comparator: Laser Photocoagulation
    Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
    Intervention: Procedure: Laser Photocoagulation
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: August 28, 2014)
221
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2008)
200
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinically significant DME with central involvement
  • Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
  • ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Exclusion Criteria:

  • History of vitreoretinal surgery in the study eye
  • Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
  • Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
  • Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
  • Ocular disorders in the study eye, other than DME, that may confound interpretation of study results
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 Austria,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00789477
Other Study ID Numbers  ICMJE VGFT-OD-0706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date August 2014

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