A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved… (NCT04503551) | Clinical Trial Compass
CompletedPhase 3
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
United States174 participantsStarted 2020-08-10
Plain-language summary
Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≤12% within 2 months prior to screening or at screening
Inclusion Criteria for Study Eye
* Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53)
* BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better)
Exclusion Criteria:
* 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
Ocular Exclusion Criteria for Study Eye:
* Presence of center-involved diabetic macular edema (defined as CST ≥325 µm)
* Any intravitreal anti-VEGF treatment at any time prior to randomization
* Any u…
What they're measuring
1
Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52