Intravitreal Alfibercept Injection 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: August 29, 2014
Last verified: August 2014

April 7, 2011
August 29, 2014
May 2011
June 2013   (final data collection date for primary outcome measure)
Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
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
  • Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
  • Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
  • Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
  • Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
  • Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
  • 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
 
Intravitreal Alfibercept Injection 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)
    Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
  • Biological: VEGF Trap-Eye (BAY86-5321)
    Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
  • Procedure: Macular Laser Photocoagulation (Control)
    Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
  • Experimental: Intravitreal Aflibercept Injection 2Q4
    Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
    Intervention: Biological: VEGF Trap-Eye (BAY86-5321)
  • Experimental: Intravitreal Aflibercept Injection 2Q8
    Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
    Intervention: Biological: VEGF Trap-Eye (BAY86-5321)
  • Active Comparator: Macular Laser Photocoagulation (Control)
    Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
    Intervention: Procedure: Macular Laser Photocoagulation (Control)
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
406
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 retinopathy (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
Italy,   Australia,   Austria,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Taiwan,   Japan,   Poland,   Spain
 
NCT01331681
91745, 2010-022364-12
Yes
Bayer
Bayer
Regeneron Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
August 2014

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