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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
NCT04503551 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
- DRUG Intravitreal Ranibizumab 0.5 mg Injection
Study Locations (20)
California
- California Retina Consultants — Bakersfield
- The Retina Partners — Encino
- Retina Consultants of Orange County;Clinical Research — Fullerton
- Jules Stein Eye Institute/ UCLA — Los Angeles
- California Eye Specialists Medical Group — Pasadena
- Kaiser Permanente;RESEARCH AND EVALUATION — Riverside
- Retina Consultants Medical Group — Sacramento
- Orange County Retina Medical Group — Santa Ana
Arizona
- Barnet Dulaney Perkins Eye Center — Mesa
- Retinal Consultants of Arizona;Opthalmology — Phoenix
- Associated Retina Consultants — Phoenix
Florida
- Retina Specialty Institute — Pensacola
- Fort Lauderdale Eye Institute — Plantation
- Retina Associates of Florida;Retina Associates of Florida — Tampa
Colorado
- Southwest Retina Research Center — Durango
- Colorado Clinical Research — Lakewood
Georgia
- Southeast Retina Center — Augusta
- Georgia Retina — Marietta
Connecticut
- Retina Group of New England — Waterford
Hawaii
- Retina Consultants of Hawaii at Pali Momi Medical Center — ‘Aiea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2026-03-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04503551
The ClinicalTrials.gov registry entry for NCT04503551 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions — of which PDS Implant Pre-Filled with 100 mg/mL Ranibizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04503551 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04503551 about?
NCT04503551 is a clinical study titled "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". 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
What is the current status of trial NCT04503551?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 2020-08-10. Estimated completion is 2026-03-02.
What conditions does trial NCT04503551 study?
This clinical trial studies the following conditions: Diabetic Retinopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04503551?
The interventions under investigation include: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab (DRUG), Intravitreal Ranibizumab 0.5 mg Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04503551?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04503551 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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