A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years at time of signing Informed Consent Form
Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
HbA1c level of ≤12% within 2 months prior to screening or at screening
Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53)
BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better)
You may not be if
Uncontrolled blood pressure
Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
Current systemic treatment for a confirmed active systemic infection
Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
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; that might affect interpretation of the results of the study; or that renders the patient at high risk for treatment complications in the opinion of the investigator or Sponsor
Presence of center-involved diabetic macular edema (defined as CST ≥325 µm)
Any intravitreal anti-VEGF treatment at any time prior to randomization
Any use of medicated intraocular implants, including Ozurdex® or Iluvien® implants at any time prior to randomization
Any intravitreal corticosteroid treatment at any time prior to randomization
Any periocular (e.g., subtenon) corticosteroid treatment at any time prior to randomization
Any PRP at any time prior to randomization
Any macular laser photocoagulation (such as micropulse and focal or grid laser) at any time prior to randomization
Active intraocular inflammation (grade trace or above)
Clinically significant abnormalities of the vitreous-retinal interface involving the macular area or disrupting the macular architecture, such as vitreous-retinal traction or epiretinal membrane (assessed by the investigator and confirmed by the central reading center)
Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
Any concurrent ocular condition (e.g., cataract, epiretinal membrane) that would require surgical intervention during the study to prevent or treat visual loss that might result from that condition
Any concurrent ocular condition (e.g., amblyopia, strabismus) that may affect interpretation of study results
History of other ocular diseases that gives reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of study results, or that renders the participant at high risk for treatment complications
Suspected or active ocular or periocular infection of either eye
Any history uveitis including idiopathic, drug-associated or autoimmune-associated uveitis
Clareo Health | A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
