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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01331681




Registration number
NCT01331681
Ethics application status
Date submitted
7/04/2011
Date registered
8/04/2011
Date last updated
19/04/2016

Titles & IDs
Public title
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
Scientific 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
Secondary ID [1] 0 0
2010-022364-12
Secondary ID [2] 0 0
91745
Universal Trial Number (UTN)
Trial acronym
VIVID-DME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VEGF Trap-Eye (BAY86-5321)
Other interventions - VEGF Trap-Eye (BAY86-5321)
Treatment: Surgery - Macular Laser Photocoagulation (Control)

Experimental: Intravitreal Aflibercept Injection 2Q4 - 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).

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.


Other interventions: VEGF Trap-Eye (BAY86-5321)
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).

Other interventions: 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).

Treatment: Surgery: 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 code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline up to Week 52
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline up to Week 52
Secondary outcome [4] 0 0
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
Timepoint [4] 0 0
Baseline up to Week 52
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline up to Week 52
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline up to Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Chatswood
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- East Melbourne
Recruitment hospital [5] 0 0
- Prahran
Recruitment hospital [6] 0 0
- Nedlands
Recruitment hospital [7] 0 0
- Parramatta
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Oberösterreich
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Hradec Kralove
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Ostrava
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha 10
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Zlin
Country [9] 0 0
Denmark
State/province [9] 0 0
Glostrup
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense C
Country [11] 0 0
Denmark
State/province [11] 0 0
Århus C
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Creteil Cedex
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
France
State/province [16] 0 0
Nantes Cedex
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Baden-Württemberg
Country [19] 0 0
Germany
State/province [19] 0 0
Bayern
Country [20] 0 0
Germany
State/province [20] 0 0
Hessen
Country [21] 0 0
Germany
State/province [21] 0 0
Niedersachsen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Rheinland-Pfalz
Country [24] 0 0
Germany
State/province [24] 0 0
Sachsen
Country [25] 0 0
Germany
State/province [25] 0 0
Schleswig-Holstein
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Debrecen
Country [29] 0 0
Hungary
State/province [29] 0 0
Veszprem
Country [30] 0 0
Hungary
State/province [30] 0 0
Zalaegerszeg
Country [31] 0 0
Italy
State/province [31] 0 0
Ancona
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Padova
Country [34] 0 0
Italy
State/province [34] 0 0
Roma
Country [35] 0 0
Japan
State/province [35] 0 0
Aichi
Country [36] 0 0
Japan
State/province [36] 0 0
Hokkaido
Country [37] 0 0
Japan
State/province [37] 0 0
Kanagawa
Country [38] 0 0
Japan
State/province [38] 0 0
Miyagi
Country [39] 0 0
Japan
State/province [39] 0 0
Nagano
Country [40] 0 0
Japan
State/province [40] 0 0
Oita
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Japan
State/province [43] 0 0
Akita
Country [44] 0 0
Japan
State/province [44] 0 0
Chiba
Country [45] 0 0
Japan
State/province [45] 0 0
Fukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Nagasaki
Country [47] 0 0
Japan
State/province [47] 0 0
Wakayama
Country [48] 0 0
Poland
State/province [48] 0 0
Bialystok
Country [49] 0 0
Poland
State/province [49] 0 0
Bytom
Country [50] 0 0
Poland
State/province [50] 0 0
Wroclaw
Country [51] 0 0
Spain
State/province [51] 0 0
A Coruña
Country [52] 0 0
Spain
State/province [52] 0 0
Asturias
Country [53] 0 0
Spain
State/province [53] 0 0
Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Alicante
Country [55] 0 0
Spain
State/province [55] 0 0
Pamplona
Country [56] 0 0
Spain
State/province [56] 0 0
Valencia
Country [57] 0 0
Taiwan
State/province [57] 0 0
Changhua
Country [58] 0 0
Taiwan
State/province [58] 0 0
Kaohsiung
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01331681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications