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Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID-DME)

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ClinicalTrials.gov Identifier: NCT01331681
Recruitment Status : Completed
First Posted : April 8, 2011
Results First Posted : September 9, 2014
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Macular Edema Biological: VEGF Trap-Eye (BAY86-5321) Procedure: Macular Laser Photocoagulation (Control) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 up to Week 52 ]
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.


Secondary Outcome Measures :
  1. 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 up to Week 52 ]
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.

  2. 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 up to Week 52 ]
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.

  3. 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 up to Week 52 ]
    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)

  4. Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF [ Time Frame: Baseline up to Week 52 ]
  5. 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 up to Week 52 ]
    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.

  6. 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 up to Week 52 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331681


Locations
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Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01331681    
Other Study ID Numbers: 91745
2010-022364-12 ( EudraCT Number )
First Posted: April 8, 2011    Key Record Dates
Results First Posted: September 9, 2014
Last Update Posted: April 19, 2016
Last Verified: March 2016
Keywords provided by Bayer:
Diabetic Macular Edema (DME)
VEGF Trap-Eye
Best-corrected visual acuity (BCVA)
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents