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Diabetic Macular EdemaPhase 4INSITE-DMENCT05610319

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 testing Faricimab in people with Diabetic Macular Edema, run by McMaster University at 46 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
46 sitesin 4 countries
Study dates
1 May 2023to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2).
  • 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.***
  • Visual impairment due to DME, with best corrected visual acuity of 80 to 20 letters (Snellen VA 20/25 - 20/400).
  • Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.
  • Hemoglobin A1c must be <10% within 2 months prior to 1st study treatment.
  • Provide signed informed consent.

Who cannot join

  • Active or history of ocular inflammation or suspected/active ocular infection in either eye.
  • High-risk proliferative diabetic retinopathy in the study eye.**
  • Tractional retinal detachment, preretinal fibrosis or visually significant epiretinal membrane involving the macula.
  • Uncontrolled glaucoma (intraocular pressure >30 with or without medications).
  • Any intravitreal, periocular or implant corticosteroids within 26 weeks (6 months) before day 1 or any use of Iluvien implants.
  • Treatment with Panretinal photocoagulation (PRP) within 12 weeks before day 1.
Show all 25Show fewer
  • Treatment with macular laser.
  • Any cataract surgery or any other intraocular surgery within 12 weeks before day 1.
  • Macular edema in study eye due to a cause other than DME.
  • 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).
  • 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)
  • 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.)
  • Women of child-bearing potential who are lactating, pregnant, or intending to become pregnant within the next 100 weeks.
  • Current or anticipated incarceration.
  • Terminal illness with expected survival less than 100 weeks.
  • Known hypersensitivity to faricimab or any of the excipients in the faricimab injection.
  • Currently enrolled in a study that does not permit co-enrollment.
  • Unable to obtain informed consent due to language or other operational barriers.
  • Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures.
  • Prior enrollment in this trial.
  • Other reason to exclude the patient, as approved by the sponsor and site investigator.
  • 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.

Trial locations and contacts

46 sites in 4 countries.

46 sites in 4 countries

Australia16 sites

  • Adelaide Eye & Retina Centre

    Adelaide, South Australia, 5000

  • Eye Clinic Albury Wodonga

    Albury, New South Wales, 2640

  • Nexus Eyecare Blacktown

    Blacktown, New South Wales

  • Eastern Suburbs Eye Specialists

    Bondi Junction, New South Wales, 2022

  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002

  • Hobart Eye Surgeons

    Hobart, Tasmania, 7008

  • Retina and Eye Consultants

    Hurstville, New South Wales, 2220

  • Lane Cove Eye

    Lane Cove, New South Wales, 2066

  • South West Retina

    Liverpool, New South Wales, 2170

  • Lions Eye Institute Limited

    Nedlands, Western Australia, 6009

  • Marsden Eye Specialists

    Parramatta, New South Wales, 2150

  • Retina Specialists Victoria

    Rowville, Victoria, 3178

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

  • South Eastern Sydney Health

    Sydney, New South Wales, 2000

  • Sydney Retina

    Sydney, New South Wales, 2000

  • Queensland Eye Institute

    Woolloongabba, Queensland, 4012

Other trials in Australia

United States11 sites

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401

  • Retina Consultants of Houston, dba Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Mississippi Retina Associates

    Jackson, Mississippi, 39202

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Retinal Consultants Medical Group Inc.

    Modesto, California, 95356

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

  • Vitreo-Retina Medical Group

    Sacramento, California, 95825

  • Retina Consultants of Houston, dba Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

Other trials in United States

Canada11 sites

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • Alberta Retina Consultants

    Calgary, Alberta, T5H 0X5

  • The Research Institute of St. Joe's Hamilton

    Hamilton, Ontario, L8G 5E4

  • St. Joseph's Healthcare London

    London, Ontario, N6A 4V2

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Retina Surgical Associates

    New Westminster, British Columbia, V3L 5H1

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9

  • Vitreous Retina Macula Specialists of Toronto

    Toronto, Ontario, M8X 2X3

  • West Coast Retina

    Vancouver, British Columbia, V5Z 1K1

  • UBC Eye Centre, Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

United Kingdom8 sites

  • Bradford Royal Infirmary

    Bradford, England

  • University Hospitals Bristol-Weston

    Bristol, England

  • Frimley Health

    Frimley, England

  • Liverpool University Hospitals

    Liverpool, England

  • King's College Hospital

    London, England

  • London North West University

    London, England

  • Moorfields Eye Hospital

    London, England

  • The Royal Wolverhampton

    Wolverhampton, England

Other trials in United Kingdom

About this study

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

Being tested
Faricimab
Keywords
Treat and Extend, Faricimab, Anti-VEGF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Faricimab will be administered via intravitreal injection.

Study groups in NCT05610319
Study groupRoleWhat they receive
Treat and ExtendExperimentalParticipants randomized to the T\&E Arm will initially receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), with treatment intervals increased/extended, reduced, or maintained based on CST assessments, until week 100.
Receives: Drug: Faricimab
Control/Usual Care ArmOtherParticipants in the control arm will receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), for 6 treatments. Afterwards, participants will continue to receive 6mg faricimab IVT every 8 weeks until week 100.
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Best Corrected Visual Acuity

    Change in best corrected visual acuity (3.9 letter non-inferiority margin)

    Measured: Baseline to Week 100

Secondary outcomes (9)

  1. Decrease in Diabetic Retinopathy Severity Score

    A 2-step improvement in diabetic retinopathy severity score

    Measured: Baseline to Week 100

  2. Decrease in Diabetic Retinopathy Severity Score

    A 3-step improvement in diabetic retinopathy severity score

    Measured: Baseline to Week 100

  3. Change in Central Subfield Thickness

    Change in central subfield thickness on OCT

    Measured: Baseline to Week 100

  4. Change in Vision Related Quality of Life

    Change in vision-related quality of life (VFQ-25)

    Measured: Baseline to Week 100

  5. Change in Letters of Vision

    Gaining or losing ≥5, ≥10, or ≥15 letters of vision

    Measured: Baseline to Week 100

  6. Absence of Diabetic Macular Edema

    Absence of diabetic macular edema in the study eye

    Measured: Week 100

  7. Absence of Intraretinal Fluid (IRF)

    Absence of intraretinal fluid (IRF) in the study eye

    Measured: Week 100

  8. Dosing Interval

    Dosing interval at week 100

    Measured: Week 100

  9. Presence of Safety Outcomes

    Safety outcomes (ocular and systemic AEs and SAEs)

    Measured: Baseline to Week 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start1 May 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-armed, parallel, non-inferiority randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
446 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610319
Sponsor's protocol ID
2022-01
Other IDs
MR44143
Acronym
INSITE-DME
Status last verified
Apr 2026
First submitted
2 Nov 2022
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Faricimab in people with Diabetic Macular Edema, run by McMaster University at 46 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Australia, United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Best Corrected Visual Acuity (time frame: Baseline to Week 100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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