Port Delivery System with Ranibizumab in patients with Diabetic Retinopathy with or without Diabetic Macular Edema

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:
    1. Participants who are 18 or older who provide written informed consent form
    2. Ability and willingness 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) 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 =10% within 2 months prior to screening or at screening
    5. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as according the protocol
    Ocular Inclusion Criteria for Study Eye:
    1. Macular thickening secondary to DME
    2. BCVA of 25 letters
    3. Sufficiently clear ocular media and adequate pupillary dilatation

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

    1. 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, or anticipated to require 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. Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
    10. Use of any systemic anti-VEGF agents
    11. Participation in an investigational trial that involves treatment with any drug or device
    12. Administration of systemic pro-angiogenic treatments
    13. Use of antimitotic or antimetabolite therapy
    14. Requirement for continuous use of any medications and treatments
    15. Pregnant or breastfeeding, or intending to become pregnant during the study
    Ocular Exclusion Criteria for Study Eye
    1. High-risk PDR
    2. Tractional retinal detachment or pre-retinal fibrosis
    3. Clinically significant abnormalities of the vitreous-retinal interface
    4. History of macular hole (stage 3 or 4)
    5. Active rubeosis
    6. Active intraocular inflammation
    7. Panretinal photocoagulation
    8. Macular laser photocoagulation
    9. Any use of medicated intraocular implants, including Ozurdex® or Iluvien® implants
    10. Intravitreal corticosteroid treatment
    11. Periocular (e.g., subtenon) corticosteroid treatment
    12. intravitreal anti-VEGF treatment
    13. Retinal tears or peripheral retinal breaks
    14. History of rhegmatogenous retinal detachment
    15. History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
    16. Uncontrolled ocular hypertension or glaucoma
    17. 25 mmHg or a cup-to-disc ratio >0.8
    18. Intraocular surgery
    19. History of corneal transplant
    20. History of pars plana vitrectomy
    21. Previous intraocular device implantation
    22. Aphakia or absence of the posterior capsule
    23. Diagnosis of concurrent or previous retinal diseases other than DR that can lead to macular edema
    24. Any concurrent ocular condition
    25. History of other ocular diseases that gives reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab



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