A Phase III Multicenter Randomized Study of the Efficacy Safety and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Diabetic Retinopathy (Pavilion)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Diabetic Macular Edema
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    General inclusion criteria
    1. Participants who are over 18 years old and able to provide written informed consent
    2. Participants who are able and willing to comply with the study protocol and to undertake all scheduled visits and assessments
    3. Documented diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the American Diabetes Association or per WHO criteria and:
      • Current regular use of insulin for the treatment of diabetes and/or
      • Current regular use of anti-hyperglycemic agents for the treatment of diabetes
    4. HbA1c level of =12% within 2 months prior to screening or at screening
    5. Willingness to adhere to recommendations/measures provided by their endocrinologist or primary care physician to aim for the best possible metabolic control during participation in the study
    6. Women of childbearing potential agreem to remain abstinent or use contraceptive measures
    Ocular Inclusion Criteria for Study Eye:
    1. Moderately severe or severe NPDR
    2. BCVA of =69 letters (20/40 approximate Snellen equivalent or better), using the ETDRS protocol at the initial testing distance of 4 meters
    3. Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center

You may not be eligible for this study if the following are true:

    1. Participant with currently untreated diabetes mellitus
    2. History of allergy or hypersensitivity to fluorescein or to any study-assessment or study treatment related mandatory ingredients
    3. Active cancer within the past 12 months
    4. Current systemic treatment for a confirmed active systemic infection
    5. Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis
    6. History of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant
    7. Uncontrolled blood pressure
    8. Cerebrovascular accident or myocardial infarction
    9. Participation in an investigational trial that involves treatment with any drug or device

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.