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

NCT01635790 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2015-07-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ranibizumab

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

DRUG

Bevacizumab

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

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Free University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Prof. dr. R.O. Schlingemann

    lead OTHER

Principal Investigators

  • Reinier O Schlingemann, MD, PhD · Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-06-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635790 on ClinicalTrials.gov