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Monoclonal Antibodies
Faricimab for Diabetic Macular Edema (INSITE-DME Trial)
Phase 4
Recruiting
Led By Dr. Varun Chaudhary, MD, FRCS(C)
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 100
Awards & highlights
INSITE-DME Trial Summary
This trial will compare 2 regimens for a medical treatment to see which is better.
Who is the study for?
Adults over 18 with diabetes (type 1 or type 2) and diabetic macular edema affecting the central vision, who have a certain level of visual impairment. Participants must have stable blood sugar control with an HbA1c under 10%. They should not have had recent eye surgery, ocular inflammation, infections, uncontrolled glaucoma, or previous treatments that could affect the trial's outcome.Check my eligibility
What is being tested?
The study is testing Faricimab for diabetic macular edema by comparing two approaches: 'treat & extend' where treatment intervals may be adjusted based on disease activity versus a fixed schedule of doses regardless of changes in symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, Faricimab as an eye injection can potentially cause discomfort at the injection site, increased intraocular pressure, bleeding inside the eye and possible allergic reactions to its components.
INSITE-DME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 100
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 100
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Best Corrected Visual Acuity
Secondary outcome measures
Absence of Diabetic Macular Edema
Absence of Intraretinal Fluid (IRF)
Change in Central Subfield Thickness
+5 moreSide effects data
From 2021 Phase 3 trial • 940 Patients • NCT0362258018%
Cataract
12%
Hypertension
11%
Diabetic retinal oedema
10%
Nasopharyngitis
8%
Conjunctival haemorrhage
6%
Urinary tract infection
4%
Vitreous detachment
4%
Intraocular pressure increased
3%
Vitreous floaters
3%
Fall
2%
Pneumonia
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Osteomyelitis
2%
Sepsis
1%
Chest pain
1%
Coronary artery disease
1%
Cellulitis
1%
Chronic kidney disease
1%
COVID-19
1%
Cerebrovascular accident
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Syncope
1%
Osteoarthritis
1%
Adenocarcinoma of colon
1%
Cellulitis gangrenous
1%
End stage renal disease
1%
Retinal artery occlusion
1%
COVID-19 pneumonia
1%
Gangrene
1%
Anaemia
1%
Acute left ventricular failure
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Diabetic retinopathy
1%
Diabetic foot infection
1%
Ischaemic stroke
1%
Renal failure
1%
Diabetic foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
C: Aflibercept 2 mg Q8W
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
INSITE-DME Trial Design
2Treatment groups
Experimental Treatment
Group I: Treat and ExtendExperimental Treatment1 Intervention
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.
Group II: Control/Usual Care ArmExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
2023
Completed Phase 3
~6720
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,597,870 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,432 Previous Clinical Trials
1,089,777 Total Patients Enrolled
Dr. Varun Chaudhary, MD, FRCS(C)Principal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye swelling is not due to diabetic macular edema.I am 18 years old or older.I have or had eye inflammation or infection.I have had laser eye treatment within the last 12 weeks.My eye scan shows swelling in the center due to diabetes.I have been treated with anti-VEGF, but it's been over 12 weeks, or it didn't work for me, or I've had DME for over 2 years.I haven't had eye injections or implants, including Iluvien, in the last 6 months.I have a history of eye conditions that could affect swelling in the eye.My vision is impaired due to DME, ranging from slightly to severely impaired.I am not pregnant, breastfeeding, or planning to become pregnant soon.My eye condition won't improve even if the swelling in my retina is treated.I have not had cataract or any eye surgery in the last 12 weeks.My eye pressure is not higher than 30, even with medication.I have been diagnosed with diabetes (type 1 or type 2).My eye condition is due to severe diabetes.I have received laser treatment for my eye condition.I have a complex retinal condition affecting my central vision.My eye swelling is due to recent eye surgery or a specific eye condition.My vision is impaired due to DME, ranging from slightly to severely impaired.I have been diagnosed with diabetes (type 1 or type 2).My eye scan shows thickening in the center due to diabetes-related damage.
Research Study Groups:
This trial has the following groups:- Group 1: Treat and Extend
- Group 2: Control/Usual Care Arm
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Treat and Extend an effective, safe method of treatment for individuals?
"Our team at Power rated Treat and Extend's safety as 3, which is the highest possible mark, because it has been approved in a Phase 4 trial."
Answered by AI
Is it feasible to join this experiment at the present time?
"This experiment, which was first advertised on May 1st of 2023 and revised recently on the 4th of same month, is actively recruiting participants according to clinicaltrials.gov."
Answered by AI
How many participants has this experiment reached its capacity for?
"Affirmative, the details available on clinicaltrials.gov display that this medical experiment is still in progress. It was initially announced to the public on May 1st 2023 and has been most recently adjusted four days later. The trial needs 446 participants from two separate sites."
Answered by AI
Who else is applying?
What site did they apply to?
University Retina and Macula Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I want to help find better treatments for those of us who have health complications due to diabetes.
PatientReceived 2+ prior treatments
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