Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME)
BRDME
1 other identifier
interventional
246
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedJuly 1, 2015
June 1, 2015
4 years
June 28, 2012
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
6 months
Secondary Outcomes (6)
The proportion of patients with a gain or loss of 15 letters or more
6 months
Change in leakage on fluorescein angiography
6 months
Change in foveal thickness by optical coherence tomography
6 months
Number of adverse events
6 months
Costs per quality adjusted life-year of the two treatments
6 months
- +1 more secondary outcomes
Study Arms (2)
Ranibizumab
ACTIVE COMPARATOR0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
Bevacizumab
ACTIVE COMPARATOR1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months
Interventions
0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prof. dr. R.O. Schlingemannlead
- University Medical Center Groningencollaborator
- Free University Medical Centercollaborator
- Erasmus Medical Centercollaborator
- Radboud University Medical Centercollaborator
- Leiden University Medical Centercollaborator
- UMC Utrechtcollaborator
Study Sites (1)
Academic Medical Center, Dept. Ophthalmology,
Amsterdam, 1105 AZ, Netherlands
Related Publications (1)
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.
PMID: 27842163DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reinier O Schlingemann, MD, PhD
Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 10, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2016
Last Updated
July 1, 2015
Record last verified: 2015-06