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

August 28, 2014 updated by: Regeneron Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
      • Victoria, British Columbia, Canada, V8V 4X3
    • Ontario
      • London, Ontario, Canada, N6A 4G5
      • Mississauga, Ontario, Canada, L4W 1W9
  • 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
    • Connecticut
      • Hamden, Connecticut, United States, 06518
      • New London, Connecticut, United States, 06320
    • 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
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Hawaii
      • Honolulu, Hawaii, United States, 96815
    • Indiana
      • Indianapolis, Indiana, United States, 46280
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Jackson, Michigan, United States, 48104
    • Missouri
      • Kansas City, Missouri, United States, 64108
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
      • Northfield, New Jersey, United States, 08225
      • Toms River, New Jersey, United States, 08753
    • New York
      • Rochester, New York, United States, 14620
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
      • Raleigh, North Carolina, United States, 27607
    • Ohio
      • Cincinnati, Ohio, United States, 45243
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • West Columbia, South Carolina, United States, 29169
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • 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, 78240
      • San Antonio, Texas, United States, 78215
    • Utah
      • Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • macular laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At week 52
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).
At week 24 and week 52
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).
At week 24 and week 52
Number of Focal Laser Treatments
Time Frame: Week 1 to week 48
Week 1 to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFT-OD-0706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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