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NCT05610319 · ClinicalTrials.gov registry record · Phase 4
Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
A Phase 4 study of Diabetic Macular Edema, sponsored by McMaster University.
- Active
- Registry status
- Phase 4
- Development phase
- 446
- Enrollment target
- 20
- Study locations
NCT05610319: Active Phase 4 study of Diabetic Macular Edema, sponsored by McMaster University.
NCT05610319 is a Phase 4 study of Diabetic Macular Edema that is active but no longer recruiting, run by McMaster University. The registered enrollment target is 446 participants, below the 3,787-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05610319, a Phase 4 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by McMaster University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 446 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Primary Outcome
Change in best corrected visual acuity (3.9 letter non-inferiority margin)
Conditions Studied
Interventions
- DRUG Faricimab
Study Locations (20)
New South Wales
- Eye Clinic Albury Wodonga - Albury
- Nexus Eyecare Blacktown - Blacktown
- Eastern Suburbs Eye Specialists - Bondi Junction
- Retina and Eye Consultants - Hurstville
- Lane Cove Eye - Lane Cove
- South West Retina - Liverpool
- Marsden Eye Specialists - Parramatta
- Strathfield Retina Clinic - Strathfield
- South Eastern Sydney Health - Sydney
Texas
- Austin Retina Associates - Austin
- Retina Consultants of Texas - Beaumont
- Retina & Vitreous of Texas - Bellaire
- Retina Consultants of Houston, dba Retina Consultants of Texas - Bellaire
- Valley Retina Institute - McAllen
- Retina Consultants of Houston, dba Retina Consultants of Texas - San Antonio
California
- Retinal Consultants Medical Group Inc. - Modesto
- Vitreo-Retina Medical Group - Sacramento
Illinois
- University Retina and Macula Associates - Oak Forest
Louisiana
- Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center - West Monroe
Mississippi
- Mississippi Retina Associates - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What the registry record for NCT05610319 still lists
NCT05610319 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 3,787-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Faricimab is the first listed.
NCT05610319 names 20 study sites across 6 states, led by New South Wales, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05610319 about?
NCT05610319 is a clinical study titled "Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial". This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
What is the current status of trial NCT05610319?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 446 participants. The study started on 2023-05-01. Estimated completion is 2026-12.
What conditions does trial NCT05610319 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT05610319?
The interventions under investigation include: Faricimab (DRUG).
Who is sponsoring clinical trial NCT05610319?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05610319 being conducted?
This trial has 20 study locations across California, Illinois, Louisiana, Mississippi, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
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 NCT05610319's enrollment target sits among peer trials
446 10th of 63 higher than 54 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema 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
-
A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema
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-
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
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-
Ocular Safety and Usability Study for FYB203 PFS
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Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
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COMPLETED · Phase 4
-
Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab
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