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Diabetic Macular EdemaPhase 2DA VINCINCT00789477

DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

A Phase 2 study testing Laser Photocoagulation and Intravitreal Aflibercept Injection in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 47 sites in 3 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

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Laser Photocoagulation and Intravitreal Aflibercept Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
47 sitesin 3 countries
Study dates
Dec 2008to Sep 2010
Phase
Phase 2
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

  • Patients with clinically significant DME with central involvement
  • Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
  • ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Who cannot join

  • History of vitreoretinal surgery in the study eye
  • Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
  • Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
  • Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
  • Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

Trial locations and contacts

47 sites in 3 countries.

47 sites in 3 countries

United States42 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Arlington, Texas, 76012

  • Study site

    Artesia, California, 90701

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bangor, Maine, 04401

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cincinnati, Ohio, 45243

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Honolulu, Hawaii, 96815

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46280

  • Study site

    Jackson, Michigan, 48104

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    McAllen, Texas, 78503

  • Study site

    Mountain View, California, 94040

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New London, Connecticut, 06320

  • Study site

    Northfield, New Jersey, 08225

  • Study site

    Ocala, Florida, 34474

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Pasadena, California, 91105

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95819

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78240

  • Study site

    Santa Ana, California, 92705

  • Study site

    Toms River, New Jersey, 08753

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Canada4 sites

  • Study site

    London, Ontario, N6A 4G5

  • Study site

    Mississauga, Ontario, L4W 1W9

  • Study site

    Vancouver, British Columbia, V5Z 3N9

  • Study site

    Victoria, British Columbia, V8V 4X3

Other trials in Canada

Austria1 site

  • Study site

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Read the detailed description

Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Being tested
Laser Photocoagulation, Intravitreal Aflibercept Injection

What participants receive

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

  • Laser PhotocoagulationProcedure or surgery

    Also called macular laser therapy

    laser every 16 weeks as needed

  • Intravitreal Aflibercept InjectionDrug

    Also called IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Study groups in NCT00789477
Study groupRoleWhat they receive
Intravitreal Aflibercept Injection .5Q4ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
Receives: Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q4ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
Receives: Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q8ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
Receives: Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2PRNExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
Receives: Drug: Intravitreal Aflibercept Injection
Laser PhotocoagulationActive comparatorFocal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Receives: Procedure: Laser Photocoagulation

What is being measured

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

  1. Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)

    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.

    Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

    Measured: At week 24

Secondary outcomes (4)

  1. Change in BCVA From Baseline to Week 52 - LOCF

    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

    Measured: At week 52

  2. Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF

    Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

    Measured: At week 24 and week 52

  3. Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF

    Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

    Measured: At week 24 and week 52

  4. Number of Focal Laser Treatments

    Measured: Week 1 to week 48

Timeline

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

  1. First posted11 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2009
  4. Study completionSep 2010

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789477
Sponsor's protocol ID
VGFT-OD-0706
Acronym
DA VINCI
Status last verified
Aug 2014
First submitted
7 Nov 2008
Last updated
9 Sep 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laser Photocoagulation and Intravitreal Aflibercept Injection in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 47 sites in 3 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 3 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada, Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) (time frame: At week 24). 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 NCT00789477.

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 Sep 2014.

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