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ACTIVE NOT RECRUITING Phase 4

Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

NCT05610319 · View on ClinicalTrials.gov ↗

Study Summary

This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.

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

FieldValue
Enrollment Target 446 participants
Start Date 2023-05-01
Est. Completion 2026-12
Phase Phase 4

Sponsor

McMaster University

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05610319

The ClinicalTrials.gov registry entry for NCT05610319 describes a study currently listed as active not recruiting. It is categorized as Phase 4, 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 446 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 13 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 Macular Edema appearing as the primary indexed condition, and to 1 intervention — of which Faricimab 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: NCT05610319 reports 20 study locations spanning 6 distinct geographic areas — top geographies include New South Wales, Texas, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05610319?

The interventions under investigation include: Faricimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05610319?

This trial is sponsored by McMaster University, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial