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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
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 100
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 100
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Best Corrected Visual Acuity
Secondary study objectives
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 • NCT0362258019%
Cataract
9%
Nasopharyngitis
8%
Conjunctival haemorrhage
7%
Hypertension
6%
Diabetic retinal oedema
6%
Vitreous detachment
5%
Vitreous floaters
5%
Fall
5%
Intraocular pressure increased
4%
Urinary tract infection
3%
Pneumonia
2%
Acute myocardial infarction
2%
Cardiac failure congestive
2%
Sepsis
2%
Renal failure
2%
COVID-19
1%
Acute kidney injury
1%
Cardiac arrest
1%
Atrial fibrillation
1%
Chronic kidney disease
1%
End stage renal disease
1%
Vitreous haemorrhage
1%
Coronary artery disease
1%
Myocardial infarction
1%
Myocardial ischaemia
1%
Diabetic retinopathy
1%
Glaucoma
1%
Chest pain
1%
Death
1%
Cellulitis
1%
Osteomyelitis
1%
Diabetes mellitus
1%
Hyperglycaemia
1%
Hyperkalaemia
1%
Cerebral infarction
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Acute respiratory failure
1%
Pleural effusion
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
C: Aflibercept 2 mg Q8W
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
906 Previous Clinical Trials
2,612,795 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,444 Previous Clinical Trials
1,092,676 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:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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