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

  • 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:

Active, not recruiting

This trial runs in
  • Hagerstown
  • Silverdale
Trial Identifier:

NCT04108156 GR40550

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      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

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