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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Laser Photocoagulation
Intravitreal Aflibercept Injection
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Intravitreal Aflibercept Injection .5Q4

Intravitreal Aflibercept Injection 2Q4

Intravitreal Aflibercept Injection 2Q8

Intravitreal Aflibercept Injection 2PRN

Laser Photocoagulation

Arm Description

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks

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

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.

Outcomes

Primary Outcome Measures

Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
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

Change in BCVA From Baseline to Week 52 - LOCF
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
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
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

Full Information

First Posted
November 7, 2008
Last Updated
August 28, 2014
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00789477
Brief Title
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Acronym
DA VINCI
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Aflibercept Injection .5Q4
Arm Type
Experimental
Arm Description
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
Arm Title
Intravitreal Aflibercept Injection 2Q4
Arm Type
Experimental
Arm Description
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
Arm Title
Intravitreal Aflibercept Injection 2Q8
Arm Type
Experimental
Arm Description
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
Arm Title
Intravitreal Aflibercept Injection 2PRN
Arm Type
Experimental
Arm Description
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
Arm Title
Laser Photocoagulation
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Laser Photocoagulation
Other Intervention Name(s)
macular laser therapy
Intervention Description
laser every 16 weeks as needed
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection
Other Intervention Name(s)
IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
Primary Outcome Measure Information:
Title
Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
Description
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).
Time Frame
At week 24
Secondary Outcome Measure Information:
Title
Change in BCVA From Baseline to Week 52 - LOCF
Description
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).
Time Frame
At week 52
Title
Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF
Description
Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Time Frame
At week 24 and week 52
Title
Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF
Description
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).
Time Frame
At week 24 and week 52
Title
Number of Focal Laser Treatments
Time Frame
Week 1 to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96815
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45243
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4X3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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