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NCT04108156 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
A Phase 3 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 634
- Enrollment target
- 20
- Study locations
NCT04108156 is a Phase 3 study of Diabetic Macular Edema that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 634 participants, below the 3,784-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04108156, a Phase 3 study of Diabetic Macular Edema, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 634 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Conditions Studied
Interventions
- DRUG PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
- DRUG Intravitreal Ranibizumab 0.5 mg Injection
- DRUG Ranibizumab refill exchange
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- Retina Consultants of Orange County;Clinical Research - Fullerton
- Jules Stein Eye Institute/ UCLA - Los Angeles
- Northern California Retina-Vitreous Associates - Mountain View
- East Bay Retina Consultants - Oakland
- Doheny Eye Institute - Pasadena
- California Eye Specialists Medical Group - Pasadena
- Retina Consultants Medical Group - Sacramento
- Zuckerberg San Francisco General Hospital and Trauma Center - San Francisco
- Orange County Retina Medical Group - Santa Ana
- California Retina Consultants;Research Department - Santa Barbara
Arizona
- Barnet Dulaney Perkins Eye Center - Mesa
- Retinal Consultants of Arizona;Opthalmology - Phoenix
- Arizona Retina and Vitreous Consultants - Phoenix
- Associated Retina Consultants - Phoenix
Colorado
- Eye Center of Northern Colorado - Fort Collins
- Colorado Clinical Research - Lakewood
Connecticut
- Retina Group of New England - Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 634 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-11-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04108156
The ClinicalTrials.gov registry entry for NCT04108156 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 634 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,784-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (83% 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 Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which PDS Implant Pre-Filled with 100 mg/mL Ranibizumab is the first listed.
NCT04108156 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04108156 about?
NCT04108156 is a clinical study titled "A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME". This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting t...
What is the current status of trial NCT04108156?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 634 participants. The study started on 2019-09-30. Estimated completion is 2027-11-16.
What conditions does trial NCT04108156 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT04108156?
The interventions under investigation include: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab (DRUG), Intravitreal Ranibizumab 0.5 mg Injection (DRUG), Ranibizumab refill exchange (DRUG).
Who is sponsoring clinical trial NCT04108156?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04108156 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.