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

Completed · Phase 3

Conditions studied: Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT04503551

Run by

Hoffmann-La Roche

People needed

174

Starts

2020-08-10

Expected to finish

2026-02-23

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• 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)

You may not qualify 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
• 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

Where it is running

• Retinal Consultants of Arizona;Opthalmology — Phoenix, Arizona, United States
• Associated Retina Consultants — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County;Clinical Research — Fullerton, California, United States
• Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
• California Eye Specialists Medical Group — Pasadena, California, United States
• Kaiser Permanente;RESEARCH AND EVALUATION — Riverside, California, United States
• Retina Consultants Medical Group — Sacramento, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• Southwest Retina Research Center — Durango, Colorado, United States
• Colorado Clinical Research — Lakewood, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Associates of Florida;Retina Associates of Florida — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina — Marietta, Georgia, United States
• Retina Consultants of Hawaii at Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Illinois Retina Associates — Joliet, Illinois, United States
• University Retina — Lemont, Illinois, United States
• Retina Associates — Lenexa, Kansas, United States
• Maine Eye Center — Portland, Maine, United States
• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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