Macular EdemaPhase 3VIVID-JapanNCT01512966
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) in people with Macular Edema, run by Bayer at 18 sites in Japan.
Trial summary
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year. 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?
- VEGF Trap-Eye (BAY86-5321)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 18 sitesJapan
- Study dates
- Jan 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
- BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Who cannot join
- 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
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Study site
Kagoshima, Kagoshima-ken, 890-8520
Study site
Kashihara, Nara, 634-8522
Study site
Kawasaki, Kanagawa, 216-8511
Study site
Kita, Kagawa-ken, 761-0793
Study site
Kobe, Hyōgo, 650-0017
Study site
Kyoto, Kyoto, 606-8507
Study site
Maebashi, Gunma, 371-8511
Study site
Matsuyama, Ehime, 790-8524
Study site
Mito, Ibaraki, 310-0015
Study site
Okayama, Okayama-ken, 700-8558
Study site
Osaka, Osaka, 537-0025
Study site
Osaka, Osaka, 558-8558
Study site
Ōtsu, Shiga, 520-2192
Study site
Saga, Saga-ken, 840-8571
Study site
Sendai, Miyagi, 984-8560
Study site
Shimotsuke, Tochigi, 329-0498
Study site
Suita, Osaka, 565-0871
Study site
Wakayama, Wakayama, 641-8510
About this study
Official title: An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.
- Conditions
- Macular Edema
- Being tested
- VEGF Trap-Eye (BAY86-5321)
- 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.
VEGF Trap-Eye (BAY86-5321)Biological
Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VTE 2Q4 first, then VTE 2Q8 | Experimental | VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) Receives: Biological: VEGF Trap-Eye (BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event collection
Measured: Week 52
Secondary outcomes (1)
Change from baseline in BCVA (best corrected visual acuity) letter score
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512966
- Sponsor's protocol ID
- 15657
- Acronym
- VIVID-Japan
- Status last verified
- Oct 2014
- First submitted
- 16 Jan 2012
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01512966
- Acronym / sponsor ID
- VIVID-Japan / 15657
- Conditions
- Macular Edema
- Keywords
- Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VTE 2Q4 first, then VTE 2Q8 | Experimental | Biological: VEGF Trap-Eye (BAY86-5321)VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
- BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEGF Trap-Eye (BAY86-5321)Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks. | Biological | VTE 2Q4 first, then VTE 2Q8 |
Primary outcome
Adverse Event collection
Time frame: Week 52
1 secondary outcome
Change from baseline in BCVA (best corrected visual acuity) letter score
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) in people with Macular Edema, run by Bayer at 18 sites in Japan.
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 3 inclusion and 3 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 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Event collection (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2014.