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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Laser Photocoagulation Drug: Intravitreal Aflibercept Injection Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravitreal Aflibercept Injection .5Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
 Drug: Intravitreal Aflibercept Injection
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
Experimental: Intravitreal Aflibercept Injection 2Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
 Drug: Intravitreal Aflibercept Injection
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
Experimental: Intravitreal Aflibercept Injection 2Q8
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
 Drug: Intravitreal Aflibercept Injection
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
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
 Drug: Intravitreal Aflibercept Injection
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
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.
 Procedure: Laser Photocoagulation
laser every 16 weeks as needed
Other Name: macular laser therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. Number of Focal Laser Treatments [ Time Frame: Week 1 to week 48 ]

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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
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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): NCT00789477


Locations
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United States, California
Artesia, California, United States, 90701
Beverly Hills, California, United States, 90211
Mountain View, California, United States, 94040
Pasadena, California, United States, 91105
Sacramento, California, United States, 95819
Santa Ana, California, United States, 92705
United States, Connecticut
Hamden, Connecticut, United States, 06518
New London, Connecticut, United States, 06320
United States, Florida
Boynton Beach, Florida, United States, 33426
Fort Lauderdale, Florida, United States, 33334
Fort Myers, Florida, United States, 33912
Ocala, Florida, United States, 34474
Palm Beach Gardens, Florida, United States, 33410
Winter Haven, Florida, United States, 33880
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Hawaii
Honolulu, Hawaii, United States, 96815
United States, Indiana
Indianapolis, Indiana, United States, 46280
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Jackson, Michigan, United States, 48104
United States, Missouri
Kansas City, Missouri, United States, 64108
United States, Nebraska
Lincoln, Nebraska, United States, 68506
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
Northfield, New Jersey, United States, 08225
Toms River, New Jersey, United States, 08753
United States, New York
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte, North Carolina, United States, 28210
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cincinnati, Ohio, United States, 45243
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Greenville, South Carolina, United States, 29605
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Houston, Texas, United States, 77030
McAllen, Texas, United States, 78503
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78240
United States, Utah
Salt Lake City, Utah, United States, 84107
Austria
Wien, Austria, 1090
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Victoria, British Columbia, Canada, V8V 4X3
Canada, Ontario
London, Ontario, Canada, N6A 4G5
Mississauga, Ontario, Canada, L4W 1W9
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: NCT00789477    
Other Study ID Numbers: VGFT-OD-0706
First Posted: November 11, 2008    Key Record Dates
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents