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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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Macular Edema
Biological: VEGF Trap-Eye (BAY86-5321)
Procedure: Macular Laser Photocoagulation (Control)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 406
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravitreal Aflibercept Injection 2Q4
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 (2Q4).
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).
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).
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01331681

  Show 90 Study Locations
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01331681     History of Changes
Other Study ID Numbers: 91745, 2010-022364-12
Study First Received: April 7, 2011
Results First Received: August 29, 2014
Last Updated: August 29, 2014
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Diabetic Macular Edema (DME)
VEGF Trap-Eye
Best-corrected visual acuity (BCVA)

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Macular Degeneration
Metabolic Diseases
Retinal Degeneration
Retinal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014