AzTrials
AzTrials

Macular EdemaPhase 3BRAVONCT00486018

A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)

A Phase 3 study testing Ranibizumab injection 0.3 mg and Ranibizumab injection 0.5 mg in people with Macular Edema and Retinal Vein Occlusion, run by Genentech, Inc..

Completed

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

Official record
Search all trials

Trial summary

This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
Ranibizumab injection 0.3 mg and Ranibizumab injection 0.5 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
397 participants
Where
No sites listed yet
Study dates
Jul 2007to Nov 2009
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

  • Willingness to provide signed Informed Consent Form
  • Age ≥ 18 years
  • For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
  • Ability and willingness to return for all scheduled visits and assessments
  • Ocular Inclusion Criterion (Study Eye):
  • Foveal center-involved macular edema secondary to BRVO
Show all 9Show fewer
  • BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent)
  • Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening [confirmed by the central reading center] and Day 0 [confirmed by the evaluating physician])
  • Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs

Who cannot join

  • History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
  • History of any anti-vascular endothelial growth factor (VEGF) treatment in fellow eye within 3 months prior to Day 0
  • History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
  • History of allergy to fluorescein
  • History of allergy to ranibizumab injection or related molecule
  • Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion
Show all 35Show fewer
  • Uncontrolled blood pressure
  • Pregnancy or lactation
  • Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)
  • Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry
  • Ocular Exclusion Criteria (Study Eye):
  • Prior episode of retinal vein occlusion (RVO)
  • Brisk afferent pupillary defect
  • History of radial optic neurotomy or sheathotomy
  • History or presence of age-related macular degeneration (AMD; dry or wet form)
  • History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
  • History of laser photocoagulation for macular edema within 4 months prior to Day 0
  • History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 4 months following randomization
  • History of intraocular corticosteroid use within 3 months prior to Day 0
  • History of pars plana vitrectomy
  • History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
  • History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
  • Previous filtration surgery in the study eye
  • History of herpetic ocular infection
  • History of ocular toxoplasmosis
  • History of rhegmatogenous retinal detachment
  • History of idiopathic central serous chorioretinopathy
  • Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
  • An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
  • Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
  • Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity
  • Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
  • Aphakia
  • Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
  • Improvement of > 10 letters on best corrected visual acuity (BCVA) between screening and Day 0

About this study

Official title: A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion

This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Being tested
Ranibizumab injection 0.3 mg, Ranibizumab injection 0.5 mg, Sham injection
Keywords
Lucentis, RVO, BRVO, Edema
Medical subject headings
Macular Edema, Retinal Vein Occlusion, Edema

What participants receive

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

  • Ranibizumab injection 0.3 mgDrug

    Also called Lucentis

    Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

  • Ranibizumab injection 0.5 mgDrug

    Also called Lucentis

    Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

  • Sham injectionDrug

    Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.

Study groups in NCT00486018
Study groupRoleWhat they receive
Sham injectionSham comparatorNot described
Receives: Drug: Sham injection
Ranibizumab injection 0.3 mgExperimentalNot described
Receives: Drug: Ranibizumab injection 0.3 mg
Ranibizumab injection 0.5 mgExperimentalNot described
Receives: Drug: Ranibizumab injection 0.5 mg

What is being measured

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

  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months

    BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.

    Measured: Baseline and 6 months

Secondary outcomes (6)

  1. Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline

    BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.

    Measured: Baseline and 6 months

  2. Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline

    BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who "gained >=15 letters" as "losing <15 letters" includes both those who gained >=15 letters and those who were "stable" (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).

    Measured: Baseline and 6 months

  3. Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6

    A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.

    Measured: 6 months

  4. Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6

    A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.

    Measured: Baseline and 6 months

  5. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6

    The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.

    Measured: Baseline and 6 months

  6. Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6

    The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.

    Measured: Baseline and 6 months

Timeline

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

  1. First posted13 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2009
  4. Study completionNov 2009

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, Investigator
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486018
Sponsor's protocol ID
FVF4165g
Acronym
BRAVO
Status last verified
Apr 2017
First submitted
11 Jun 2007
Last updated
10 May 2017

Publications

  • Suner IJ, Bressler NM, Varma R, Lee P, Dolan CM, Ward J, Colman S, Rubio RG. Reading speed improvements in retinal vein occlusion after ranibizumab treatment. JAMA Ophthalmol. 2013 Jul;131(7):851-6. doi: 10.1001/jamaophthalmol.2013.114.

    PubMed 23699977

  • Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.

    PubMed 23415775

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab injection 0.3 mg and Ranibizumab injection 0.5 mg in people with Macular Edema and Retinal Vein Occlusion, run by Genentech, Inc..

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 9 inclusion and 35 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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 25 Feb 2011). 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?

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (time frame: Baseline and 6 months). 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 NCT00486018, 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 10 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in