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Diabetes MellitusPhase 3VIVID-DMENCT01331681

Intravitreal Aflibercept Injection in Vision Impairment Due to DME

A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) in people with Diabetes Mellitus and Macular Edema, run by Bayer at 73 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Macular Edema
What is being tested?
VEGF Trap-Eye (BAY86-5321)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
73 sitesin 11 countries
Study dates
9 May 2011to 30 Mar 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

73 sites in 11 countries.

73 sites in 11 countries

Japan18 sites

  • Study site

    Akita, 010-8543

  • Study site

    Asahikwa, Hokkaido, 078-8510

  • Study site

    Chiba, 260-8677

  • Study site

    Chiyoda-ku, Tokyo, 101-8309

  • Study site

    Fukuoka, 812-8582

  • Study site

    Hirakata, Osaka, 573-1191

  • Study site

    Kawasaki, Kanagawa, 216-8511

  • Study site

    Matsumoto, Nagano, 390-8621

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagasaki, 852-8501

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Osaka, 545-8586

  • Study site

    Sapporo, Hokkaido, 060-8648

  • Study site

    Sendai, Miyagi, 980-8574

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    tabashi City, Tokyo, 173-8606

  • Study site

    Wakayama, 641-8510

Other trials in Japan

Germany13 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, 12203

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Darmstadt, Hesse, 64297

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Kiel, Schleswig-Holstein, 24105

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81675

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Spain7 sites

  • Study site

    Alicante, 03016

  • Study site

    Barcelona, 8036

  • Study site

    Oviedo, Principality of Asturias, 33012

  • Study site

    Pamplona, 31008

  • Study site

    San Cugat Del Vallès, Barcelona, 08190

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Valencia, 46015

Other trials in Spain

France6 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Créteil, 94010

  • Study site

    Lyon, 69003

  • Study site

    Nantes, 44093

  • Hopital Lariboisiere

    Paris, 75010

  • Study site

    Paris, 75015

Other trials in France

Hungary6 sites

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Debrecen, 4032

  • Study site

    Veszprém, 8200

  • Study site

    Zalaegerszeg, H-8900

Other trials in Hungary

Italy6 sites

  • Study site

    Ancona, The Marches, 60126

  • Study site

    Milan, Lombardy, 20157

  • IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Study site

    Padova, Veneto, 35128

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00198

Other trials in Italy

Australia5 sites

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Parramatta, 2150

  • Study site

    Sydney, New South Wales, 2000

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Czechia4 sites

  • Faculty Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Study site

    Olomouc, 779 00

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 100 34

Other trials in Czechia

Austria3 sites

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Linz, 4021

  • Study site

    Vienna, 1090

Other trials in Austria

Poland3 sites

  • Study site

    Bytom, 41-902

  • Study site

    Wroclaw, 50-556

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Denmark2 sites

  • Study site

    Århus C, 8000

  • Study site

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

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

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

Being tested
VEGF Trap-Eye (BAY86-5321), Macular Laser Photocoagulation (Control)
Keywords
Diabetic Macular Edema (DME), VEGF Trap-Eye, Best-corrected visual acuity (BCVA)
Medical subject headings
Diabetes Mellitus, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VEGF Trap-Eye (BAY86-5321)Biological

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

  • VEGF Trap-Eye (BAY86-5321)Biological

    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).

  • Macular Laser Photocoagulation (Control)Procedure or surgery

    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.

Study groups in NCT01331681
Study groupRoleWhat they receive
Intravitreal Aflibercept Injection 2Q4ExperimentalParticipants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Receives: Biological: VEGF Trap-Eye (BAY86-5321)
Intravitreal Aflibercept Injection 2Q8ExperimentalParticipants 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).
Receives: Biological: VEGF Trap-Eye (BAY86-5321)
Macular Laser Photocoagulation (Control)Active comparatorParticipants 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.
Receives: Procedure: Macular Laser Photocoagulation (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.

    Measured: Baseline up to Week 52

Secondary outcomes (6)

  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

    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.

    Measured: Baseline up to Week 52

  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

    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.

    Measured: Baseline up to Week 52

  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

    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)

    Measured: Baseline up to Week 52

  4. Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF

    Measured: 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

    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.

    Measured: Baseline up to Week 52

  6. 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.

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2011 (estimated)
  2. Study start9 May 2011
  3. Primary completion3 Jun 2013
  4. Study completion30 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331681
Sponsor's protocol ID
91745
Other IDs
2010-022364-12
Acronym
VIVID-DME
Status last verified
Nov 2023
First submitted
7 Apr 2011
Last updated
27 Nov 2023
Data monitoring committee
Yes

Publications

  • Nanegrungsunk O, Gu SZ, Bressler SB, Du W, Amer F, Moini H, Bressler NM. Correlation of Change in Macular Thickness With Change in Visual Acuity in Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials. J Vitreoretin Dis. 2022 Jul 27;6(4):284-289. doi: 10.1177/24741264221099429. eCollection 2022 Jul-Aug.

    PubMed 37007927

  • Valentim CCS, Singh RP, Du W, Moini H, Talcott KE. Time to Resolution of Diabetic Macular Edema after Treatment with Intravitreal Aflibercept Injection or Laser in VISTA and VIVID. Ophthalmol Retina. 2023 Jan;7(1):24-32. doi: 10.1016/j.oret.2022.07.004. Epub 2022 Jul 14.

    PubMed 35843487

  • 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.

    PubMed 35440699

  • 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.

    PubMed 25012934

  • 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.

    PubMed 26198808

  • 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.

    PubMed 26056030

  • Do DV, Gordon C, Suner IJ, Reed K, Moini H, Gibson A, Du W, Shah CP. Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials. J Vitreoretin Dis. 2022 Jun 4;6(4):295-301. doi: 10.1177/24741264221093914. eCollection 2022 Jul-Aug.

    PubMed 37007930

  • Dhoot DS, Moini H, Reed K, Silva FQ, Berliner A, Du W, Sharma S. INCIDENCE OF NEW DIABETIC MACULAR EDEMA IN FELLOW EYES OF PATIENTS IN THE VISTA AND VIVID STUDIES. Retina. 2023 Feb 1;43(2):254-262. doi: 10.1097/IAE.0000000000003658. Epub 2022 Oct 17.

    PubMed 36265076

  • 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.

    PubMed 29785301

  • 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.

    PubMed 29051325

  • 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.

    PubMed 28006063

  • 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.

    PubMed 27847634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) in people with Diabetes Mellitus and Macular Edema, run by Bayer at 73 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Japan, Germany, Spain, France, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01331681, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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