VEGF Trap-Eye in Vision Impairment Due to DME (VIVID-DME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01331681
First received: April 7, 2011
Last updated: February 10, 2014
Last verified: February 2014

April 7, 2011
February 10, 2014
May 2011
June 2013   (final data collection date for primary outcome measure)
Change from baseline of BCVA in ETDRS letter score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Change from baseline of BCVA in ETDRS letter score. [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01331681 on ClinicalTrials.gov Archive Site
  • Change in retinal thickness from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 1 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 2 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain threshold 1 change from baseline in visual acuity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain threshold 2 change from baseline in visual acuity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain a threshold change from baseline in the diabetic retinopathy severity score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in retinal thickness from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain a threshold change from baseline in visual acuity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 1 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 2 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
VEGF Trap-Eye in Vision Impairment Due to DME
A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Macular Edema
  • Biological: VEGF Trap-Eye (BAY86-5321)
    VEGF Trap-Eye Regimen 1
  • Biological: VEGF Trap-Eye (BAY86-5321)
    VEGF Trap-Eye Regimen 2
  • Procedure: Laser treatment
    Macular laser photocoagulation using modified ETDRS protocol
  • Experimental: Arm 1
    Intervention: Biological: VEGF Trap-Eye (BAY86-5321)
  • Experimental: Arm 2
    Intervention: Biological: VEGF Trap-Eye (BAY86-5321)
  • Active Comparator: Arm 3
    Intervention: Procedure: Laser treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
404
April 2015
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults ≥ 18 years with type 1 or 2 diabetes mellitus
  • Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
  • Decrease in vision determined to be primarily the result of DME in the study eye
  • BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

  • Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
  • More than 2 previous macular laser treatments in the study eye
  • Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
  • Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
  • Active proliferative diabetic retinopathie (PDR) in the study eye, with the exception of inactive, regressed PDR
  • Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
  • Only 1 functional eye even if that eye is otherwise eligible for the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Italy,   Japan,   Poland,   Spain,   Taiwan
 
NCT01331681
91745, 2010-022364-12
Yes
Bayer
Bayer
Regeneron Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP