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Macular EdemaPhase 3VIVID EASTNCT01783886

Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

A Phase 3 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Macular Laser Photocoagulation in people with Macular Edema, run by Bayer at 25 sites in 4 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
Macular Edema
What is being tested?
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Macular Laser Photocoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
381 participants
Where
25 sitesin 4 countries
Study dates
Feb 2013to 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 diabetic macular edema (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
  • Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (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
  • 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

25 sites in 4 countries.

25 sites in 4 countries

China17 sites

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100083

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 2000080

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chongqing, 400042

  • Study site

    Guangzhou, Guangdong, 510064

  • Study site

    Hangzhou, Zhejiang, 310009

  • Study site

    Qingdao, Shandong

  • Study site

    Shanghai

  • Study site

    Shenyang, Liaoning, 110034

  • Study site

    Tianjin

  • Study site

    Wenzhou, Zhejiang

  • Study site

    Wuhan, Hubei, 430040

  • Study site

    Xi'an, Shaanxi, 710032

Other trials in China

Russia4 sites

  • Study site

    Moscow, 105062

  • Study site

    Moscow, 127486

  • Study site

    Novosibirsk, 630071

  • Study site

    Saint Petersburg, 197022

Other trials in Russia

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

Other trials in Hong Kong

South Korea2 sites

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 138-736

Other trials in South Korea

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.

Conditions
Macular Edema
Being tested
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321), Macular Laser Photocoagulation
Keywords
Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)
Medical subject headings
Macular Edema

What participants receive

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

  • Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Biological

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

  • Aflibercept (Eylea, 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 PhotocoagulationProcedure 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 NCT01783886
Study groupRoleWhat they receive
Intravitreal Aflibercept Injection 2Q4ExperimentalParticipants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
Receives: Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intravitreal Aflibercept Injection 2Q8ExperimentalParticipants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
Receives: Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Macular Laser PhotocoagulationActive 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 over 48 weeks.
Receives: Procedure: Macular Laser Photocoagulation

What is being measured

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

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) 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, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.

    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 Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF

    ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (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

    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.

    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 posted5 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionMar 2015
  4. Study completionMar 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
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01783886
Sponsor's protocol ID
15161
Acronym
VIVID EAST
Status last verified
Apr 2016
First submitted
1 Feb 2013
Last updated
12 May 2016
Data monitoring committee
Yes

Publications

  • Chen YX, Li XX, Yoon YH, Sun X, Astakhov Y, Xu G, Wang H, Ren X, Asmus F; VIVID-East investigators. Intravitreal Aflibercept versus Laser Photocoagulation in Asian Patients with Diabetic Macular Edema: The VIVID-East Study. Clin Ophthalmol. 2020 Mar 9;14:741-750. doi: 10.2147/OPTH.S235267. eCollection 2020.

    PubMed 32210527

  • Ming J, Zhang Y, Xu X, Zhao M, Wang Y, Chen Y, Zhang F, Wang J, Liu J, Zhao X, Han R, Hu S. Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China. J Comp Eff Res. 2020 Feb;9(3):161-175. doi: 10.2217/cer-2019-0174. Epub 2020 Jan 6.

    PubMed 31904267

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Macular Laser Photocoagulation in people with Macular Edema, run by Bayer at 25 sites in 4 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China, Russia, Hong Kong, South Korea. 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 5 Apr 2016). 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 Best Corrected Visual Acuity (BCVA) 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 NCT01783886, which also lists 2 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 12 May 2016.

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