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DME And VEGF Trap-Eye: INvestigation of Clinical Impact (DA VINCI)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00789477
First received: November 7, 2008
Last updated: May 2, 2011
Last verified: May 2011
History of Changes
  Purpose

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of VEGF Trap-Eye in subjects with diabetic macular edema. Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.


Condition Intervention Phase
Diabetic Macular Edema
 Biological: VEGF Trap-Eye
Procedure: macular laser therapy
 Phase 2

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 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)

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:
  • Change in best corrected visual acuity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in foveal thickness [ Time Frame: Weeks 24 and 52 ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1
 Biological: VEGF Trap-Eye
Intravitreal injection, repeating dose
Other Name: VEGF Trap-eye
Experimental: 2
Dose 2
 Biological: VEGF Trap-Eye
Intravitreal injection, repeating dose
Other Name: VEGF Trap-eye
Experimental: 3
Dose 3
 Biological: VEGF Trap-Eye
Intravitreal injection, repeating dose
Other Name: VEGF Trap-eye
Experimental: 4
Dose 4
 Biological: VEGF Trap-Eye
Intravitreal injection, repeating dose
Other Name: VEGF Trap-eye
Active Comparator: 5
Non-drug comparator
 Procedure: macular laser therapy
laser every 16 weeks as needed
Other Name: laser photocoagulation

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789477

  Show 47 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
Study Director: Robert L Vitti, MD Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Regeneron Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00789477     History of Changes
Other Study ID Numbers: VGFT-OD-0706
Study First Received: November 7, 2008
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Ethikkommission

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013