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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05610319




Registration number
NCT05610319
Ethics application status
Date submitted
2/11/2022
Date registered
9/11/2022
Date last updated
17/10/2024

Titles & IDs
Public title
Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
Scientific title
Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
Secondary ID [1] 0 0
MR44143
Secondary ID [2] 0 0
2022-01
Universal Trial Number (UTN)
Trial acronym
INSITE-DME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab

Experimental: Treat and Extend - Participants 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.

Other: Control/Usual Care Arm - Participants 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.


Treatment: Drugs: Faricimab
Faricimab will be administered via intravitreal injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Best Corrected Visual Acuity
Timepoint [1] 0 0
Baseline to Week 100
Secondary outcome [1] 0 0
Decrease in Diabetic Retinopathy Severity Score
Timepoint [1] 0 0
Baseline to Week 100
Secondary outcome [2] 0 0
Decrease in Diabetic Retinopathy Severity Score
Timepoint [2] 0 0
Baseline to Week 100
Secondary outcome [3] 0 0
Change in Central Subfield Thickness
Timepoint [3] 0 0
Baseline to Week 100
Secondary outcome [4] 0 0
Change in Vision Related Quality of Life
Timepoint [4] 0 0
Baseline to Week 100
Secondary outcome [5] 0 0
Change in Letters of Vision
Timepoint [5] 0 0
Baseline to Week 100
Secondary outcome [6] 0 0
Absence of Diabetic Macular Edema
Timepoint [6] 0 0
Week 100
Secondary outcome [7] 0 0
Absence of Intraretinal Fluid (IRF)
Timepoint [7] 0 0
Week 100
Secondary outcome [8] 0 0
Dosing Interval
Timepoint [8] 0 0
Week 100
Secondary outcome [9] 0 0
Presence of Safety Outcomes
Timepoint [9] 0 0
Baseline to Week 100

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
446
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Eye Clinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Nexus Eyecare Blacktown - Blacktown
Recruitment hospital [3] 0 0
Eastern Suburbs Eye Specialists - Bondi Junction
Recruitment hospital [4] 0 0
Retina and Eye Consultants - Hurstville
Recruitment hospital [5] 0 0
Lane Cove Eye - Lane Cove
Recruitment hospital [6] 0 0
South West Retina - Liverpool
Recruitment hospital [7] 0 0
Marsden Eye Specialists - Parramatta
Recruitment hospital [8] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [9] 0 0
South Eastern Sydney Health - Sydney
Recruitment hospital [10] 0 0
Sydney Retina - Sydney
Recruitment hospital [11] 0 0
Queensland Eye Institute - Woolloongabba
Recruitment hospital [12] 0 0
Adelaide Eye & Retina Centre - Adelaide
Recruitment hospital [13] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [14] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [15] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [16] 0 0
Lions Eye Institute Limited - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
- Blacktown
Recruitment postcode(s) [3] 0 0
2022 - Bondi Junction
Recruitment postcode(s) [4] 0 0
2220 - Hurstville
Recruitment postcode(s) [5] 0 0
2066 - Lane Cove
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2150 - Parramatta
Recruitment postcode(s) [8] 0 0
2135 - Strathfield
Recruitment postcode(s) [9] 0 0
2000 - Sydney
Recruitment postcode(s) [10] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
7008 - Hobart
Recruitment postcode(s) [13] 0 0
3002 - East Melbourne
Recruitment postcode(s) [14] 0 0
3178 - Rowville
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Mississippi
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
United Kingdom
State/province [10] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Trial website
https://clinicaltrials.gov/study/NCT05610319
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Varun Chaudhary, MD, FRCS(C)
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gina Del Fabbro, BPH
Address 0 0
Country 0 0
Phone 0 0
905-525-9140
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05610319