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Can fewer eye injections work just as well? new trial tests flexible dosing for diabetic macular edema

NCT ID NCT05610319

Disease control Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of giving faricimab, a drug injected into the eye, to treat diabetic macular edema (DME). One group gets injections on a fixed monthly schedule, while the other uses a 'treat and extend' approach where the time between injections is gradually lengthened if the eye remains stable. The goal is to see if the flexible schedule can maintain vision with fewer clinic visits. About 446 adults with DME are taking part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Faricimab (injected into the eye)
What this could lead to
If successful, this could show that a flexible dosing schedule works as well as fixed monthly injections, potentially reducing the number of eye injections patients need.
What could go wrong
This is a Phase 4 trial comparing two already-approved dosing strategies, so it is not testing a new drug. The flexible schedule may not be as effective for all patients, and eye injections carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 446 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Diagnosis of diabetes mellitus (type 1 or type 2). 3. Macular thickening secondary to DME (CI-DME) involving the center of the fovea on Optical Coherence Tomography - Central subfield thickness (CST) ≥ 325 μm on Spectralis at screening.\*\*\* 4. Visual impairment due to DME, with best corrected visual acuity of 80 to 20 letters (Snellen VA 20/25 - 20/400). 5. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs. 6. Hemoglobin A1c must be \<10% within 2 months prior to 1st study treatment. 7. Provide signed informed consent. Exclusion Criteria: 1. Active or history of ocular inflammation or suspected/active ocular infection in either eye. 2. High-risk proliferative diabetic retinopathy in the study eye.\*\* 3. Tractional retinal detachment, preretinal fibrosis or visually significant epiretinal membrane involving the macula. 4. Uncontrolled glaucoma (intraocular pressure \>30 with or without medications). 5. Any intravitreal, periocular or implant corticosteroids within 26 weeks (6 months) before day 1 or any use of Iluvien implants. 6. Treatment with Panretinal photocoagulation (PRP) within 12 weeks before day 1. 7. Treatment with macular laser. 8. Any cataract surgery or any other intraocular surgery within 12 weeks before day 1. 9. Macular edema in study eye due to a cause other than DME. 10. If clinical exam and/or OCT and/or wide-field fluorescein angiography (WF-FA) suggest that (a) macular edema is considered to be related to ocular surgery such as cataract extraction or (b) if primary cause for macular edema is vitreoretinal interface abnormalities (e.g. a taut posterior hyaloid or epiretinal membrane). 11. Any ocular condition is present such that visual acuity loss would not improve from resolution of macular edema in opinion of the investigator (e.g. foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition) 12. Any history of ocular conditions that might affect macular edema (e.g. vein occlusion, idiopathic or infectious or non-infectious uveitis, ocular inflammatory disease, neovascular glaucoma etc.) 13. Women of child-bearing potential who are lactating, pregnant, or intending to become pregnant within the next 100 weeks. 14. Current or anticipated incarceration. 15. Terminal illness with expected survival less than 100 weeks. 16. Known hypersensitivity to faricimab or any of the excipients in the faricimab injection. 17. Currently enrolled in a study that does not permit co-enrollment. 18. Unable to obtain informed consent due to language or other operational barriers. 19. Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures. 20. Prior enrollment in this trial. 21. Other reason to exclude the patient, as approved by the sponsor and site investigator. 22. Previous treatment with anti-VEGF and: * \<12 weeks prior to day 1 (washout period).\*or, * Diagnosis of DME is \> 2 years of enrollment or, * Do not have a demonstrated response to anti-VEGF treatment based on clinical discretion.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Adelaide Eye & Retina Centre

    Adelaide, South Australia, 5000, Australia

  • Alberta Retina Consultants

    Calgary, Alberta, T5H 0X5, Canada

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Bradford Royal Infirmary

    Bradford, England, United Kingdom

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8, Canada

  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Eastern Suburbs Eye Specialists

    Bondi Junction, New South Wales, 2022, Australia

  • Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291, United States

  • Eye Clinic Albury Wodonga

    Albury, New South Wales, 2640, Australia

  • Frimley Health

    Frimley, England, United Kingdom

  • Hobart Eye Surgeons

    Hobart, Tasmania, 7008, Australia

  • King's College Hospital

    London, England, United Kingdom

  • Lane Cove Eye

    Lane Cove, New South Wales, 2066, Australia

  • Lions Eye Institute Limited

    Nedlands, Western Australia, 6009, Australia

  • Liverpool University Hospitals

    Liverpool, England, United Kingdom

  • London North West University

    London, England, United Kingdom

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4, Canada

  • Marsden Eye Specialists

    Parramatta, New South Wales, 2150, Australia

  • Mississippi Retina Associates

    Jackson, Mississippi, 39202, United States

  • Moorfields Eye Hospital

    London, England, United Kingdom

  • Nexus Eyecare Blacktown

    Blacktown, New South Wales, Australia

  • Queensland Eye Institute

    Woolloongabba, Queensland, 4012, Australia

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Houston, dba Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Houston, dba Retina Consultants of Texas

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas

    Beaumont, Texas, 77707, United States

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Specialists Victoria

    Rowville, Victoria, 3178, Australia

  • Retina Surgical Associates

    New Westminster, British Columbia, V3L 5H1, Canada

  • Retina and Eye Consultants

    Hurstville, New South Wales, 2220, Australia

  • Retinal Consultants Medical Group Inc.

    Modesto, California, 95356, United States

  • South Eastern Sydney Health

    Sydney, New South Wales, 2000, Australia

  • South West Retina

    Liverpool, New South Wales, 2170, Australia

  • St. Joseph's Healthcare London

    London, Ontario, N6A 4V2, Canada

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135, Australia

  • Sydney Retina

    Sydney, New South Wales, 2000, Australia

  • The Research Institute of St. Joe's Hamilton

    Hamilton, Ontario, L8G 5E4, Canada

  • The Royal Wolverhampton

    Wolverhampton, England, United Kingdom

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9, Canada

  • UBC Eye Centre, Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • University Hospitals Bristol-Weston

    Bristol, England, United Kingdom

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452, United States

  • Valley Retina Institute

    McAllen, Texas, 78503, United States

  • Vitreo-Retina Medical Group

    Sacramento, California, 95825, United States

  • Vitreous Retina Macula Specialists of Toronto

    Toronto, Ontario, M8X 2X3, Canada

  • West Coast Retina

    Vancouver, British Columbia, V5Z 1K1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.