Back to resultsIntravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID-DME)
Primary Purpose
Diabetes Mellitus, Macular Edema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VEGF Trap-Eye (BAY86-5321)
VEGF Trap-Eye (BAY86-5321)
Macular Laser Photocoagulation (Control)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic Macular Edema (DME), VEGF Trap-Eye, Best-corrected visual acuity (BCVA)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intravitreal Aflibercept Injection 2Q4
Intravitreal Aflibercept Injection 2Q8
Macular Laser Photocoagulation (Control)
Arm Description
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
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).
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.
Outcomes
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)
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
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
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
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
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
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
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.
Full Information
NCT ID
NCT01331681
First Posted
April 7, 2011
Last Updated
March 20, 2016
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01331681
Brief Title
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
Acronym
VIVID-DME
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Macular Edema
Keywords
Diabetic Macular Edema (DME), VEGF Trap-Eye, Best-corrected visual acuity (BCVA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal Aflibercept Injection 2Q4
Arm Type
Experimental
Arm Description
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Arm Title
Intravitreal Aflibercept Injection 2Q8
Arm Type
Experimental
Arm Description
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).
Arm Title
Macular Laser Photocoagulation (Control)
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
VEGF Trap-Eye (BAY86-5321)
Intervention Description
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Intervention Type
Biological
Intervention Name(s)
VEGF Trap-Eye (BAY86-5321)
Intervention Description
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 Type
Procedure
Intervention Name(s)
Macular Laser Photocoagulation (Control)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Time Frame
Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Description
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Time Frame
Baseline up to Week 52
Title
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Description
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Time Frame
Baseline up to Week 52
Title
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
Description
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)
Time Frame
Baseline up to Week 52
Title
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
Title
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
Description
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.
Time Frame
Baseline up to Week 52
Title
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
Description
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.
Time Frame
Baseline up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Prahran
State/Province
Victoria
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
City
Linz
ZIP/Postal Code
4021
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
City
Lyon
ZIP/Postal Code
69003
Country
France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
City
Paris
ZIP/Postal Code
75006
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44892
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
06067
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
City
Ancona
ZIP/Postal Code
60126
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20157
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Roma
ZIP/Postal Code
00198
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Asahikwa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
City
San Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08190
Country
Spain
City
Alicante
ZIP/Postal Code
03016
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25012934
Citation
Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.
Results Reference
result
PubMed Identifier
26198808
Citation
Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, Heier JS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Korobelnik JF. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):2044-52. doi: 10.1016/j.ophtha.2015.06.017. Epub 2015 Jul 18.
Results Reference
result
PubMed Identifier
26056030
Citation
Keating GM. Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Drugs. 2015 Jul;75(10):1153-60. doi: 10.1007/s40265-015-0421-y.
Results Reference
result
PubMed Identifier
35440699
Citation
Dhoot DS, Moini H, Reed K, Du W, Vitti R, Berliner AJ, Singh RP. Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials. Eye (Lond). 2023 Jul;37(10):2020-2025. doi: 10.1038/s41433-022-02058-7. Epub 2022 Apr 19.
Results Reference
derived
PubMed Identifier
29785301
Citation
Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.
Results Reference
derived
PubMed Identifier
29051325
Citation
Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.
Results Reference
derived
PubMed Identifier
28006063
Citation
Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.
Results Reference
derived
PubMed Identifier
27847634
Citation
Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. doi: 10.1186/s40942-016-0041-z. eCollection 2016.
Results Reference
derived
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Intravitreal Aflibercept Injection in Vision Impairment Due to DME
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