Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Del...
Eligibility Criteria
Inclusion
- 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
- 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 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
- Ocular Exclusion Criteria for Either Eye
- Suspected or active ocular or periocular infection of either eye
- Any history uveitis including idiopathic, drug-associated or autoimmune-associated uveitis
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04503551
Start Date
August 10 2020
End Date
January 31 2026
Last Update
November 25 2025
Active Locations (64)
Enter a location and click search to find clinical trials sorted by distance.
1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206
2
Retinal Consultants of Arizona;Opthalmology
Phoenix, Arizona, United States, 85014
3
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
4
California Retina Consultants
Bakersfield, California, United States, 93309