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NCT04503551 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study of Diabetic Retinopathy, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT04503551: Active Phase 3 study of Diabetic Retinopathy, sponsored by Hoffmann-La Roche.
NCT04503551 is a Phase 3 study of Diabetic Retinopathy that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 174 participants, below the 1,673-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503551, a Phase 3 study of Diabetic Retinopathy, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. The Cochran-Mantel Ha
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 |
What the registry record for NCT04503551 still lists
NCT04503551 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 1,673-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower).
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.
NCT04503551 names 20 study sites across 7 states, led by California, Arizona, Florida.
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.
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).
Who is sponsoring clinical trial NCT04503551?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04503551's enrollment target sits among peer trials
174 30th of 57 higher than 28 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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