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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00789477
First received: November 7, 2008
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Diabetic Macular Edema
Procedure: Laser Photocoagulation
Drug: Intravitreal Aflibercept Injection
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:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 221
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: 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

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
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, see Learn About Clinical Studies.

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

  Show 47 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00789477     History of Changes
Other Study ID Numbers: VGFT-OD-0706
Study First Received: November 7, 2008
Results First Received: August 28, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Ethikkommission

Additional relevant MeSH terms:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014