This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab (PDS) in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab

  • Diabetic Macular Edema
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Millcreek
  • Norfolk
Trial Identifier:

NCT04108156 GR40550

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04108156 , GR40550 Trial Identifier
      PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection Treatments
      Diabetic Macular Edema Condition
      Official Title

      A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Age ≥18 years at time of signing Informed Consent Form
      • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
      • HbA1c level of ≤10% within 2 months prior to screening or at screening

      Study eye

      • Macular thickening secondary to DME involving the center of the fovea with CST ≥325 um on SD-OCT at screening
      • BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)
      Exclusion Criteria
      • High-risk proliferative diabetic retinopathy
      • Active intraocular inflammation (grade trace or above)
      • Suspected or active ocular or periocular infection of either eye
      • Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
      • Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
      • Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
      • Uncontrolled blood pressure

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

       

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