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

Diabetic Macular Edema Clinical Trial

— INSITE-DME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610319
• Other study ID #: 2022-01
• Secondary ID: MR44143
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: McMaster University
• Contact: Gina Del Fabbro, BPH
• Phone: 905-525-9140
• Email: delfabbg[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 446
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Faricimab
Faricimab will be administered via intravitreal injection.

Locations

Country	Name	City	State
Australia	Adelaide Eye & Retina Centre	Adelaide	South Australia
Australia	Eye Clinic Albury Wodonga	Albury	New South Wales
Australia	Eastern Suburbs Eye Specialists	Bondi Junction	New South Wales
Australia	Centre for Eye Research Australia	East Melbourne	Victoria
Australia	Hobart Eye Surgeons	Hobart	Tasmania
Australia	Retina and Eye Consultants	Hurstville	New South Wales
Australia	Lane Cove Eye	Lane Cove	New South Wales
Australia	South West Retina	Liverpool	New South Wales
Australia	Lions Eye Institute Limited	Nedlands	Western Australia
Australia	Marsden Eye Specialists	Parramatta	New South Wales
Australia	Retina Specialists Victoria	Rowville	Victoria
Australia	Strathfield Retina Clinic	Strathfield	New South Wales
Australia	South Eastern Sydney Health	Sydney	New South Wales
Australia	Sydney Retina	Sydney	New South Wales
Australia	Queensland Eye Institute	Woolloongabba	Queensland
Canada	Alberta Retina Consultants	Calgary	Alberta
Canada	Calgary Retina Consultants	Calgary	Alberta
Canada	The Research Institute of St. Joe's Hamilton	Hamilton	Ontario
Canada	St. Joseph's Healthcare London	London	Ontario
Canada	Maisonneuve-Rosemont Hospital	Montréal	Quebec
Canada	Retina Surgical Associates	New Westminster	British Columbia
Canada	Retina Institute of Ottawa	Ottawa	Ontario
Canada	University of Ottawa Eye Institute	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Retina Institute	Toronto	Ontario
Canada	UHN Toronto Western Hospital	Toronto	Ontario
Canada	Vitreous Retina Macula Specialists of Toronto	Toronto	Ontario
Canada	UBC Eye Centre, Vancouver General Hospital	Vancouver	British Columbia
Canada	West Coast Retina	Vancouver	British Columbia
United Kingdom	Bradford Royal Infirmary	Bradford	England
United Kingdom	University Hospitals Bristol-Weston	Bristol	England
United Kingdom	Frimley Health	Frimley	England
United Kingdom	Liverpool University Hospitals	Liverpool	England
United Kingdom	King's College Hospital	London	England
United Kingdom	London North West University	London	England
United Kingdom	Moorfields Eye Hospital	London	England
United Kingdom	Manchester University	Manchester	England
United Kingdom	The Royal Wolverhampton	Wolverhampton	England
United States	Austin Retina Associates	Austin	Texas
United States	Retina Consultants of Texas	Beaumont	Texas
United States	Retina & Vitreous of Texas	Bellaire	Texas
United States	Retina Consultants of Houston, dba Retina Consultants of Texas	Bellaire	Texas
United States	Mississippi Retina Associates	Jackson	Mississippi
United States	Valley Retina Institute	McAllen	Texas
United States	Retinal Consultants Medical Group Inc.	Modesto	California
United States	University Retina and Macula Associates	Oak Forest	Illinois
United States	Vitreo-Retina Medical Group	Sacramento	California
United States	Retina Consultants of Houston, dba Retina Consultants of Texas	San Antonio	Texas
United States	Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center	West Monroe	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Corrected Visual Acuity	Change in best corrected visual acuity (3.9 letter non-inferiority margin)	Baseline to Week 100
Secondary	Decrease in Diabetic Retinopathy Severity Score	A 2-step improvement in diabetic retinopathy severity score	Baseline to Week 100
Secondary	Decrease in Diabetic Retinopathy Severity Score	A 3-step improvement in diabetic retinopathy severity score	Baseline to Week 100
Secondary	Change in Central Subfield Thickness	Change in central subfield thickness on OCT	Baseline to Week 100
Secondary	Change in Vision Related Quality of Life	Change in vision-related quality of life (VFQ-25)	Baseline to Week 100
Secondary	Change in Letters of Vision	Gaining or losing =5, =10, or =15 letters of vision	Baseline to Week 100
Secondary	Absence of Diabetic Macular Edema	Absence of diabetic macular edema in the study eye	Week 100
Secondary	Absence of Intraretinal Fluid (IRF)	Absence of intraretinal fluid (IRF) in the study eye	Week 100
Secondary	Dosing Interval	Dosing interval at week 100	Week 100
Secondary	Presence of Safety Outcomes	Safety outcomes (ocular and systemic AEs and SAEs)	Baseline to Week 100