search
Back to results

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

Primary Purpose

Diabetic Macular Edema

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Faricimab
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Treat and Extend, Faricimab, Anti-VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • University Retina and Macula AssociatesRecruiting
  • Eye Associates of Northeast Louisiana Dba Haik Humble Eye CenterRecruiting
  • Retina Consultants of Houston, dba Retina Consultants of TexasRecruiting
  • Valley Retina InstituteRecruiting
  • Retina Consultants of Houston, dba Retina Consultants of TexasRecruiting
  • Eye Clinic Albury WodongaRecruiting
  • Eastern Suburbs Eye Specialists
  • Retina and Eye ConsultantsRecruiting
  • Lane Cove Eye
  • South West RetinaRecruiting
  • Marsden Eye SpecialistsRecruiting
  • Strathfield Retina ClinicRecruiting
  • South Eastern Sydney Health
  • Sydney Retina
  • Coastal Eye Centre
  • Queensland Eye Institute
  • Adelaide Eye & Retina CentreRecruiting
  • Hobart Eye SurgeonsRecruiting
  • Centre for Eye Research Australia
  • Retina Specialists Victoria
  • Lions Eye Institute Limited
  • Calgary Retina ConsultantsRecruiting
  • Alberta Retina ConsultantsRecruiting
  • Retina Surgical AssociatesRecruiting
  • West Coast RetinaRecruiting
  • UBC Eye Centre, Vancouver General Hospital
  • The Research Institute of St. Joe's HamiltonRecruiting
  • St. Joseph's Healthcare LondonRecruiting
  • University of Ottawa Eye Institute
  • Retina Institute of OttawaRecruiting
  • Toronto Retina InstituteRecruiting
  • Sunnybrook Health Sciences Centre
  • UHN Toronto Western Hospital
  • Vitreous Retina Macula Specialists of TorontoRecruiting
  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treat and Extend

Control/Usual Care Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Best Corrected Visual Acuity
Change in best corrected visual acuity (3.9 letter non-inferiority margin)

Secondary Outcome Measures

Decrease in Diabetic Retinopathy Severity Score
A 2-step improvement in diabetic retinopathy severity score
Decrease in Diabetic Retinopathy Severity Score
A 3-step improvement in diabetic retinopathy severity score
Change in Central Subfield Thickness
Change in central subfield thickness on OCT
Change in Vision Related Quality of Life
Change in vision-related quality of life (VFQ-25)
Change in Letters of Vision
Gaining or losing ≥5, ≥10, or ≥15 letters of vision
Absence of Diabetic Macular Edema
Absence of diabetic macular edema in the study eye
Absence of Intraretinal Fluid (IRF)
Absence of intraretinal fluid (IRF) in the study eye
Dosing Interval
Dosing interval at week 100
Presence of Safety Outcomes
Safety outcomes (ocular and systemic AEs and SAEs)

Full Information

First Posted
November 2, 2022
Last Updated
October 10, 2023
Sponsor
McMaster University
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT05610319
Brief Title
Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Treat and Extend, Faricimab, Anti-VEGF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two-armed, parallel, non-inferiority randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
446 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treat and Extend
Arm Type
Experimental
Arm Description
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.
Arm Title
Control/Usual Care Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Faricimab
Intervention Description
Faricimab will be administered via intravitreal injection.
Primary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity
Description
Change in best corrected visual acuity (3.9 letter non-inferiority margin)
Time Frame
Baseline to Week 100
Secondary Outcome Measure Information:
Title
Decrease in Diabetic Retinopathy Severity Score
Description
A 2-step improvement in diabetic retinopathy severity score
Time Frame
Baseline to Week 100
Title
Decrease in Diabetic Retinopathy Severity Score
Description
A 3-step improvement in diabetic retinopathy severity score
Time Frame
Baseline to Week 100
Title
Change in Central Subfield Thickness
Description
Change in central subfield thickness on OCT
Time Frame
Baseline to Week 100
Title
Change in Vision Related Quality of Life
Description
Change in vision-related quality of life (VFQ-25)
Time Frame
Baseline to Week 100
Title
Change in Letters of Vision
Description
Gaining or losing ≥5, ≥10, or ≥15 letters of vision
Time Frame
Baseline to Week 100
Title
Absence of Diabetic Macular Edema
Description
Absence of diabetic macular edema in the study eye
Time Frame
Week 100
Title
Absence of Intraretinal Fluid (IRF)
Description
Absence of intraretinal fluid (IRF) in the study eye
Time Frame
Week 100
Title
Dosing Interval
Description
Dosing interval at week 100
Time Frame
Week 100
Title
Presence of Safety Outcomes
Description
Safety outcomes (ocular and systemic AEs and SAEs)
Time Frame
Baseline to Week 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Del Fabbro, BPH
Phone
905-525-9140
Ext
21852
Email
delfabbg@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Carruthers
Phone
905-327-5635
Ext
24392
Email
carrutj@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Varun Chaudhary, MD, FRCS(C)
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Retina and Macula Associates
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Vallejo
First Name & Middle Initial & Last Name & Degree
Veeral Sheth, MD
Facility Name
Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharoon David
First Name & Middle Initial & Last Name & Degree
Ruben Grigorian, MD
Facility Name
Retina Consultants of Houston, dba Retina Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheryl Hanson
First Name & Middle Initial & Last Name & Degree
Charles Wykoff, MD
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaney Capetillo
First Name & Middle Initial & Last Name & Degree
Victor H Gonzalez, MD
Facility Name
Retina Consultants of Houston, dba Retina Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan San Roman
First Name & Middle Initial & Last Name & Degree
Emily Gonzales
First Name & Middle Initial & Last Name & Degree
Jeremiah Brown, MD
Facility Name
Eye Clinic Albury Wodonga
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherie Byrne
First Name & Middle Initial & Last Name & Degree
Dr. Trung Dang
Facility Name
Eastern Suburbs Eye Specialists
City
Bondi Junction
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Jeong
First Name & Middle Initial & Last Name & Degree
Dr. Matthew Simunovic
Facility Name
Retina and Eye Consultants
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Corica
First Name & Middle Initial & Last Name & Degree
Dr. Derek Chan
Facility Name
Lane Cove Eye
City
Lane Cove
State/Province
New South Wales
ZIP/Postal Code
2066
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xanthe Harrison
First Name & Middle Initial & Last Name & Degree
Dr. Samantha Fraser-Bell
Facility Name
South West Retina
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Tsang
First Name & Middle Initial & Last Name & Degree
Dr. Gerald Liew
Facility Name
Marsden Eye Specialists
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trish Forsyth
First Name & Middle Initial & Last Name & Degree
Dr. Jennifer Arnold
Facility Name
Strathfield Retina Clinic
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarrvesa Singh
First Name & Middle Initial & Last Name & Degree
Dr. Hemal Mehta
Facility Name
South Eastern Sydney Health
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon McKenzie
First Name & Middle Initial & Last Name & Degree
Dr. Samantha Fraser-Bell
Facility Name
Sydney Retina
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hong
First Name & Middle Initial & Last Name & Degree
Dr. Andrew Chang
Facility Name
Coastal Eye Centre
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadene Townsend
First Name & Middle Initial & Last Name & Degree
Dr. Thomas Campbell
Facility Name
Queensland Eye Institute
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Caldwell
First Name & Middle Initial & Last Name & Degree
Dr. Abhishek Sharma
Facility Name
Adelaide Eye & Retina Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerin Haywood
First Name & Middle Initial & Last Name & Degree
Dr. Jaghit Gilhotra
Facility Name
Hobart Eye Surgeons
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7008
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beverley Curry
First Name & Middle Initial & Last Name & Degree
Dr. Nitin Verma
Facility Name
Centre for Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thuy Chau
First Name & Middle Initial & Last Name & Degree
Dr. Robyn Troutbeck
Facility Name
Retina Specialists Victoria
City
Rowville
State/Province
Victoria
ZIP/Postal Code
3178
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thuy Chau
First Name & Middle Initial & Last Name & Degree
Dr. Sanjeewa Wickremasinghe
Facility Name
Lions Eye Institute Limited
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoAnne Forest
First Name & Middle Initial & Last Name & Degree
Dr. Fred Chen
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norah Hanna
First Name & Middle Initial & Last Name & Degree
Geoff Williams, MD
Facility Name
Alberta Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T5H 0X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Pilisko
First Name & Middle Initial & Last Name & Degree
Matthew Tennant, MD
Facility Name
Retina Surgical Associates
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 5H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramil Lovete
First Name & Middle Initial & Last Name & Degree
Dr. Robert Gizicki
Facility Name
West Coast Retina
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumi Ohashi
First Name & Middle Initial & Last Name & Degree
Garnet Elvena
First Name & Middle Initial & Last Name & Degree
David Albiani, MD
Facility Name
UBC Eye Centre, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mannie Fan
First Name & Middle Initial & Last Name & Degree
Dr. Wai-Ching Lam
Facility Name
The Research Institute of St. Joe's Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorell Gantioqui
Email
gantioj@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Eugene Wu
Email
wue9@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Varun Chaudhary, MD, FRCS(C)
Facility Name
St. Joseph's Healthcare London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Duncan
First Name & Middle Initial & Last Name & Degree
Dr. Tom Sheidow
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Schindler
First Name & Middle Initial & Last Name & Degree
Dr. Bernard Hurley
Facility Name
Retina Institute of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald
First Name & Middle Initial & Last Name & Degree
Kayleigh Corbet
First Name & Middle Initial & Last Name & Degree
Raman Tuli
Facility Name
Toronto Retina Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3C 0G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paviya Navanathan
First Name & Middle Initial & Last Name & Degree
Dr. David Chow
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faryal Maniyali
First Name & Middle Initial & Last Name & Degree
Dr. Peter Kertes
Facility Name
UHN Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Hung
First Name & Middle Initial & Last Name & Degree
Dr. Michael Brent
Facility Name
Vitreous Retina Macula Specialists of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8X 2X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Sukovic
First Name & Middle Initial & Last Name & Degree
Netan Choudhry, MD
Facility Name
Maisonneuve-Rosemont Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigufa Kahn
First Name & Middle Initial & Last Name & Degree
Dr. Cynthia Qian

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs