A Study of RO6867461 in Participants With Center-involving Diabetic Macular Edema (BOULEVARD)

  • Eye Disorder
  • Diabetic Macular Edema
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT02699450 RG7716 BP30099

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02699450, BP30099, RG7716 Trial Identifier
      RO6867461, Ranibizumab, Faricimab Treatments
      Diabetic Macular Edema Condition
      Official Title

      A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 36-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Macular edema associated with diabetic retinopathy
      • Decreased visual acuity attributable primarily to DME
      • Diagnosis of diabetes mellitus
      Exclusion Criteria
      • High risk proliferative diabetic retinopathy
      • Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
      • Uncontrolled glaucoma
      • Current or history of ocular disease in the study eye other than DME
      • Major illness or major surgical procedure within 1 month prior to Day 1
      • Uncontrolled blood pressure
      • Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening
      • Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1

      For the latest version of this information please go to www.forpatients.roche.com

       

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