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

November 5, 2023 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Parramatta, Australia, 2150
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Linz, Austria, 4021
      • Wien, Austria, 1090
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Faculty Hospital Hradec Kralove
      • Olomouc, Czechia, 779 00
      • Ostrava, Czechia, 708 52
      • Praha 10, Czechia, 100 34
  • Denmark
      • Glostrup, Denmark, 2600
      • Århus C, Denmark, 8000
  • France
      • Bordeaux, France, 33076
      • Creteil Cedex, France, 94010
      • Lyon, France, 69003
      • Nantes Cedex, France, 44093
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75015
  • Germany
      • Berlin, Germany, 12203
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Heidelberg, Baden-Württemberg, Germany, 69120
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
    • Hessen
      • Darmstadt, Hessen, Germany, 64297
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Köln, Nordrhein-Westfalen, Germany, 50924
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Debrecen, Hungary, 4032
      • Veszprem, Hungary, 8200
      • Zalaegerszeg, Hungary, H-8900
  • Italy
      • Milano, Italy, 20122
        • IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
    • Lazio
      • Roma, Lazio, Italy, 00198
      • Roma, Lazio, Italy, 00133
    • Lombardia
      • Milano, Lombardia, Italy, 20157
    • Marche
      • Ancona, Marche, Italy, 60126
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Japan
      • Akita, Japan, 010-8543
      • Chiba, Japan, 260-8677
      • Fukuoka, Japan, 812-8582
      • Nagasaki, Japan, 852-8501
      • Osaka, Japan, 545-8586
      • Wakayama, Japan, 641-8510
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
      • Nagoya, Aichi, Japan, 467-8602
    • Hokkaido
      • Asahikwa, Hokkaido, Japan, 078-8510
      • Sapporo, Hokkaido, Japan, 060-8648
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Itabashi-ku, Tokyo, Japan, 173-8606
      • Mitaka, Tokyo, Japan, 181-8611
      • Shinjuku-ku, Tokyo, Japan, 162-8666
  • Poland
      • Bytom, Poland, 41-902
      • Wroclaw, Poland, 50-556
      • Wroclaw, Poland, 51-124
  • Spain
      • Alicante, Spain, 03016
      • Barcelona, Spain, 8036
      • Pamplona, Spain, 31008
      • Valencia, Spain, 46015
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Asturias
      • Oviedo, Asturias, Spain, 33012
    • Barcelona
      • San Cugat Del Vallès, Barcelona, Spain, 08190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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).
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).
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 (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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 52
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.
Baseline up to Week 52
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)
Baseline up to Week 52
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
Baseline up to Week 52
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.
Baseline up to Week 52
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.
Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2011

Primary Completion (Actual)

June 3, 2013

Study Completion (Actual)

March 30, 2015

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimated)

April 8, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91745
  • 2010-022364-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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