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Branch Retinal Vein OcclusionPhase 3VIBRANTNCT01521559

Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)

A Phase 3 study testing Macular Laser Photocoagulation and Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in people with Branch Retinal Vein Occlusion, run by Regeneron Pharmaceuticals at 56 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 III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Branch Retinal Vein Occlusion
What is being tested?
Macular Laser Photocoagulation and Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
56 sitesin 3 countries
Study dates
Apr 2012to Mar 2014
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

  • The following inclusion criteria include, but are not limited to:
  • Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
  • ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
  • Provide signed informed consent

Who cannot join

  • The following exclusion criteria include, but are not limited to:
  • Current bilateral manifestation of BRVO
  • Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
  • Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
  • Uncontrolled diabetes mellitus (DM)
  • Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
Show all 10Show fewer
  • Use of periocular corticosteroids in the study eye within 3 months before day 1
  • Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
  • Previous administration of systemic anti-angiogenic medications
  • Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye

Trial locations and contacts

56 sites in 3 countries.

56 sites in 3 countries

United States45 sites

  • Study site

    Abilene, Texas

  • Study site

    Augusta, Georgia

  • Study site

    Baltimore (2 Locations), Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Boston (2 Locations), Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Colorado Springs, Colorado

  • Study site

    Florence, South Carolina

  • Study site

    Florissant, Missouri

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Grand Rapids, Michigan

  • Study site

    Hagerstown, Maryland

  • Study site

    Harlingen, Texas

  • Study site

    Houston, Texas

  • Study site

    Jackson, Michigan

  • Study site

    Kingston, Pennsylvania

  • Study site

    La Jolla, California

  • Study site

    Ladson, South Carolina

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Nebraska

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mountain View, California

  • Study site

    Nashville, Tennessee

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orchard Park, New York

  • Study site

    Palm Desert, California

  • Study site

    Phoenix, Arizona

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Rapid City, South Dakota

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    Seattle, Washington

  • Study site

    Southfield, Michigan

  • Study site

    Stuart, Florida

  • Study site

    Syracuse, New York

  • Study site

    Tampa, Florida

  • Study site

    Teaneck, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    West Columbia, South Carolina

  • Study site

    West Mifflin, Pennsylvania

  • Study site

    Winter Haven, Florida

Other trials in United States

Japan7 sites

  • Study site

    Amagasaki, Hyōgo

  • Study site

    Fukushima, Fukushima

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Kagoshima, Kagoshima-ken

  • Study site

    Kyoto, Kyoto

  • Study site

    Osaka, Osaka

  • Study site

    Urayasu-shi, Chiba

Other trials in Japan

Canada4 sites

  • Study site

    Mississauga, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

About this study

Official title: A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

Being tested
Macular Laser Photocoagulation, Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Medical subject headings
Retinal Vein Occlusion

What participants receive

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

  • Macular Laser PhotocoagulationProcedure or surgery

  • Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)Drug

Study groups in NCT01521559
Study groupRoleWhat they receive
Macular Laser Photocoagulation Treatment (Control)Sham comparatorParticipants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
Receives: Procedure: Macular Laser Photocoagulation
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4ExperimentalParticipants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
Receives: Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

What is being measured

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

  1. Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF

    Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.

    Measured: Baseline to week 24

Secondary outcomes (3)

  1. Change From Baseline to Week 24 in BCVA Score - LOCF

    Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.

    Measured: Baseline to Week 24

  2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

    CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).

    Measured: Baseline to week 24

  3. Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - 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 to week 24

Timeline

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

  1. First posted30 Jan 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2013
  4. Study completionMar 2014

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521559
Sponsor's protocol ID
VGFTe-RVO-1027
Acronym
VIBRANT
Status last verified
Nov 2014
First submitted
26 Jan 2012
Last updated
13 Nov 2014
Data monitoring committee
No

Publications

  • Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.

    PubMed 32633861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Macular Laser Photocoagulation and Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in people with Branch Retinal Vein Occlusion, run by Regeneron Pharmaceuticals at 56 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 4 inclusion and 10 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Japan, Canada. 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. Some participants in this study may receive a placebo. 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 13 Nov 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?

Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF (time frame: Baseline to 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 NCT01521559, which also lists 1 linked publication.

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 13 Nov 2014.

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