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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 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.
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
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,673-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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