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Diabetic Macular EdemaPhase 2/3BRDMENCT01635790

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME)

A Phase 2/3 study testing Ranibizumab and Bevacizumab in people with Diabetic Macular Edema, run by Prof. dr. R.O. Schlingemann at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the change in best-corrected visual acuity (BCVA) 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
Diabetic Macular Edema
What is being tested?
Ranibizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 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 who have signed an informed consent;
  • Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization (WHO) guidelines) with glycosylated haemoglobin (HbA1c) less than 12.0% at screening (Visit 1). Patients should be on a dietary, exercise and/or pharmacological program for diabetes. Treatment for diabetes must have been stable for at least 2 months;
  • Patients with visual impairment due to DME (within the EDTRS criteria of clinically significant macular edema) in at least one eye, with a central area thickness >275 ìm, who are eligible for anti-VEGF treatment according to the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at visit 1, will be selected by the investigator as the study eye;
  • 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 meter (approximate Snellen equivalent of 20/32 to 20/320).

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 (grade + or above) in either eye at enrolment;
  • Any active infection (e.g., conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) 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 m of the centre 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 glaucoma in the study eye at screening (IOP > 24 mmHg on medication or according to investigator's judgment);
  • Neovascularization of the iris in the study eye;
  • Evidence of vitreomacular traction in the study eye;
  • Active untreated proliferative diabetic retinopathy in the study eye;
  • Any intraocular surgery in the study eye within 3 months prior to randomization;
  • History of vitrectomy in study eye regardless of time 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 (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, VEGF-Trap, etc.) within 3 months prior to randomization;
  • Use of other investigational drugs at the time of enrolment, or within 3 month or 5 half-lives from enrolment, whichever is longer;
  • History of intravitreal corticosteroids in phakic eye within 18 months prior to randomization or in post-cataract surgery study eye (aphakic or pseudophakic, without damaged posterior capsule) 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;
  • Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening;
  • Blood pressure systolic > 165 mm Hg or diastolic > 105 mmHg at screening and randomization;
  • Hypertension or change in antihypertensive treatment within 1 month preceding 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, ranibizumab or bevacizumab 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;
  • Concomitant conditions in the study eye which would, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment;
  • 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 neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia).

Trial locations and contacts

1 site in 1 country.

Reinier O Schlingemann, MD, PhD contact

+31 20 5663682

r.schlingemann@amc.uva.nl

Monique Wezel contact

+31 20 5663616

m.wezel@amc.uva.nl

Netherlands1 site, 1 recruiting

  • Academic Medical Center, Dept. Ophthalmology,

    Amsterdam, 1105 AZ

    Recruiting

Other trials in Netherlands

About this study

Official title: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (The BRDME Study)

The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.

Read the detailed description

Objective: To compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during 6 months. It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness.

Study design: This will be a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands.

Study population: patients 18 years of age or higher with diabetic macular 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 best-corrected visual acuity (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 and costs per quality adjusted life-year of the two treatments.

Keywords
bevacizumab, ranibizumab, diabetic macular edema, randomized clinical trial

What participants receive

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

  • RanibizumabDrug

    Also called Lucentis

    0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months

  • BevacizumabDrug

    Also called Avastin

    1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months

Study groups in NCT01635790
Study groupRoleWhat they receive
RanibizumabActive comparator0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
Receives: Drug: Ranibizumab; Drug: Bevacizumab
BevacizumabActive comparator1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months
Receives: Drug: Ranibizumab; Drug: Bevacizumab

What is being measured

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

  1. Best Corrected Visual Acuity

    Primary outcome measure will be the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.

    Measured: 6 months

Secondary outcomes (6)

  1. The 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

  2. Change in leakage on fluorescein angiography

    Change in leakage on fluorescein angiography, baseline compared to 6 month exit visit

    Measured: 6 months

  3. Change in foveal thickness by optical coherence tomography

    The change in foveal thickness (central retinal area) by optical coherence tomography, 6 month exit visit compared to baseline

    Measured: 6 months

  4. Number of adverse events

    The total number of adverse events that occured during the 6 month study timeframe, with secondary a classification of the types of adverse events

    Measured: 6 months

  5. 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

  6. 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.

  1. First posted10 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2016 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01635790
Sponsor's protocol ID
NL35860.018.11
Acronym
BRDME
Status last verified
Jun 2015
First submitted
28 Jun 2012
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Fickweiler W, Klaassen I, Vogels IM, Hooymans JM, Wolffenbuttel BH, Los LI, Schlingemann RO; BRDME Research Group. Association of Circulating Markers With Outcome Parameters in the Bevacizumab and Ranibizumab in Diabetic Macular Edema Trial. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6234-6241. doi: 10.1167/iovs.16-20157.

    PubMed 27842163

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ranibizumab and Bevacizumab in people with Diabetic Macular Edema, run by Prof. dr. R.O. Schlingemann 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 4 inclusion and 29 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, MD, PhD (+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?

On the ClinicalTrials.gov record for NCT01635790, 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 1 Jul 2015.

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