Retinal Vein OcclusionPhase 2/3BRVONCT01635803
Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)
A Phase 2/3 study testing Bevacizumab and Ranibizumab in people with Retinal Vein Occlusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Bevacizumab and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 2/3
- 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
- Male or female patients > 18 years of age with vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion diagnosed within 6 months before study initiation, who have signed an informed consent;
- BCVA equal or more than 24 and less or equal to 78 letters in the study eye at screening using ETDRS- like visual acuity testing charts at a testing distance of 4 meters
- Mean central subfield thickness more than 275 micron on 2 OCT measurements.
Who cannot join
- Women of child-bearing potential.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (human chorionic gonadotropin > 5 mIU/ml);
- Inability to comply with study procedures;
- Active intraocular inflammation in either eye at enrolment;
- Any active infection in either eye at the time of enrolment;
- History of uveitis in either eye at any time;
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- Structural damage within 600 micron of the center of the macula in the study eye likely to preclude improvement in visual acuity following in the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques;
- Uncontrolled (neovascular) glaucoma in the study eye at screening. (IOP > 24 mmHg on medication or according to investigator's judgment);
- Evidence of vitreomacular traction in the study eye;
- Patients who are monocular or have a Snellen VA in the non-study eye ≤ 1/300 at visit 1;
- Any intraocular surgery in the study eye within 3 months prior to randomization;
- Planned medical or surgical intervention during the 6-months study period;
- Panretinal laser photocoagulation in the study eye within 3 months prior to or during the study;
- Focal/grid laser photocoagulation in the study eye 3 months prior to study entry;
- Treatment with anti-angiogenic drugs in the study eye within 3 months prior to randomization;
- Use of other investigational drugs at the time of enrolment, or within 3 months or 5 half-lives from enrolment, whichever is longer;
- History of intravitreal corticosteroids in study eye within 4 months prior to randomization;
- Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids;
- History of stroke or transient ischemic attack (TIA) within 6 months prior to enrolment;
- History of myocardial infarction within 3 months prior to randomization;
- Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol;
- Known hypersensitivity to fluorescein, bevacizumab or ranibizumab or any component thereof or drugs of similar chemical classes;
- Any type of advanced, severe or unstable disease or its treatment, that may interfere with primary and/or secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extend that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk;
- Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 6 month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularisation of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia);
- Prior episode of RVO;
- Evidence on examination of sight-threatening diabetic retinopathy.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center, Dept. Ophthalmology
Amsterdam, 1105 AZ
Reinier O Schlingemann, MD, PhD, +31 205663682, r.schlingemann@amc.uva.nl
Monique Wezel, +31 205663616, m.wezel@amc.uva.nl
About this study
Official title: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (The BRVO Study)
The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6.
Read the detailed description
Objective: to compare the effectiveness and costs of 1.25 mg bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during 6 months.
Study Design: This will be a randomized, controlled, double masked, clinical trial in 296 patients in 7 academic trial centres in The Netherlands.
Study population: patients older than 18 years of age with macular edema secondary to a retinal vein occlusion and a best corrected visual acuity (BCVA) score between 78 and 20 letters in the study eye.
Outcomes: The primary outcome measure will be the change in BCVA in the study eye from baseline to month 6.
Secondary outcomes will be amongst others the proportion of patients with a gain of 15 letters or more and/or a BCVA of 20/40 or more at 6 months and the costs per quality adjusted life-year of the two treatments
- Conditions
- Retinal Vein Occlusion
- Being tested
- Bevacizumab, Ranibizumab
- Keywords
- bevacizumab, ranibizumab, retinal vein occlusions, randomized clinical trial, Macular edema
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
RanibizumabDrug
Also called Lucentis
0.5mg ranibizumab administered by monthly interval for six months (6 injections).
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | Monthly injections with ranibizumab during 6 months Receives: Drug: Ranibizumab |
| Bevacizumab | Active comparator | Monthly injections with bevacizumab during 6 months Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter.
Measured: 6 months
Secondary outcomes (6)
Proportion of patients with a gain or loss of 15 letters or more
The proportion of patients with a gain or loss of 15 letters or more at 6 months compared to baseline BCVA
Measured: 6 months
Change in leakage on fluorescein angiography
The change in leakage on fluorescein angiography at the 6 month exit visit compared to baseline
Measured: 6 months
Change in foveal thickness by optical coherence tomography
The change in foveal thickness (central area thickness) by optical coherence tomography at 6 months compared to baseline
Measured: 6 months
The number of adverse events
The number of adverse events that occurred in the time frame of 6 months and a classification of the type of adverse events
Measured: 6 months
Costs per quality adjusted life-year of the two treatments
The costs per quality adjusted life-year of the two treatments, results will be based on the use of standardized health questionnaires (EQ5D or HUI3)
Measured: 6 months
The proportion of patients with a BCVA of 20/40 or more
The proportion of patients with a BCVA of 20/40 or more at 6 months compared to baseline BCVA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Universitair Ziekenhuis Brussel, Erasmus Medical Center, Radboud University Medical Center, UMC Utrecht, University Medical Center Groningen
- Responsible party
- Principal investigator, Prof. dr. R.O. Schlingemann, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Reinier O Schlingemann, MD, PhD, Principal investigator, Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635803
- Sponsor's protocol ID
- NL35869.018.11
- Acronym
- BRVO
- Status last verified
- Jun 2015
- First submitted
- 28 Jun 2012
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (The BRVO Study)
- ClinicalTrials.gov ID
- NCT01635803
- Acronym / sponsor ID
- BRVO / NL35869.018.11
- Conditions
- Retinal Vein Occlusion
- Keywords
- bevacizumab, ranibizumab, retinal vein occlusions, randomized clinical trial, Macular edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Leiden University Medical Center, Universitair Ziekenhuis Brussel, Erasmus Medical Center, Radboud University Medical Center, UMC Utrecht, University Medical Center Groningen
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- First posted
- 10 Jul 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.
The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6.
Detailed description
Objective: to compare the effectiveness and costs of 1.25 mg bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during 6 months.
Study Design: This will be a randomized, controlled, double masked, clinical trial in 296 patients in 7 academic trial centres in The Netherlands.
Study population: patients older than 18 years of age with macular edema secondary to a retinal vein occlusion and a best corrected visual acuity (BCVA) score between 78 and 20 letters in the study eye.
Outcomes: The primary outcome measure will be the change in BCVA in the study eye from baseline to month 6.
Secondary outcomes will be amongst others the proportion of patients with a gain of 15 letters or more and/or a BCVA of 20/40 or more at 6 months and the costs per quality adjusted life-year of the two treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: RanibizumabMonthly injections with ranibizumab during 6 months |
| Bevacizumab | Active comparator | Drug: BevacizumabMonthly injections with bevacizumab during 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients > 18 years of age with vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion diagnosed within 6 months before study initiation, who have signed an informed consent;
- BCVA equal or more than 24 and less or equal to 78 letters in the study eye at screening using ETDRS- like visual acuity testing charts at a testing distance of 4 meters
- Mean central subfield thickness more than 275 micron on 2 OCT measurements.
Key exclusion criteria (26 listed)
- Women of child-bearing potential.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (human chorionic gonadotropin > 5 mIU/ml);
- Inability to comply with study procedures;
- Active intraocular inflammation in either eye at enrolment;
- Any active infection in either eye at the time of enrolment;
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 |
|---|---|---|
| BevacizumabAlso: Avastin1.25 mg bevacizumab administered by monthly interval for six months (6 injections). | Drug | Bevacizumab |
| RanibizumabAlso: Lucentis0.5mg ranibizumab administered by monthly interval for six months (6 injections). | Drug | Ranibizumab |
Primary outcome
Best corrected visual acuity
Time frame: 6 months
The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter.
6 secondary outcomes
Proportion of patients with a gain or loss of 15 letters or more
Time frame: 6 months
Change in leakage on fluorescein angiography
Time frame: 6 months
Change in foveal thickness by optical coherence tomography
Time frame: 6 months
The number of adverse events
Time frame: 6 months
Costs per quality adjusted life-year of the two treatments
Time frame: 6 months
The proportion of patients with a BCVA of 20/40 or more
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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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.
Reinier O Schlingemann, MD, PhD principal investigator
Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab and Ranibizumab in people with Retinal Vein Occlusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 26 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: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinier O Schlingemann, PhD, MD (+31 20 5663682, r.schlingemann@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 6 months). 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 1 Jul 2015.