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Monoclonal Antibodies

Faricimab injection for Diabetic Retinopathy

Phase 4
Waitlist Available
Research Sponsored by University of Colorado, Denver
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 through study completion, an average of 1 year
Awards & highlights

Summary

In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.

Who is the study for?
This trial is for adults over 18 with non-clearing vitreous hemorrhage due to diabetic retinopathy, who are undergoing eye surgery. They must be able to follow the study plan and use effective contraception if of childbearing potential. Those unable to commit or at risk of not complying with contraceptive guidelines are excluded.
What is being tested?
The study tests whether Vabysmo (Faricimab) injections before eye surgery can reduce complications compared to a sham treatment in patients with diabetic-related bleeding in the eye. Participants will be randomly assigned to receive either the real drug or a placebo.
What are the potential side effects?
While specific side effects for this trial aren't listed, Faricimab may generally cause irritation at the injection site, increased intraocular pressure, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rates of post-operative vitreous hemorrhage
Secondary study objectives
BCVA outcomes
Duration of operative time.
Number of endodiathermy use exchanges intra-operatively.
+5 more

Side effects data

From 2021 Phase 3 trial • 940 Patients • NCT03622580
19%
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%
Atrial fibrillation
1%
Cardiac arrest
1%
End stage renal disease
1%
Acute kidney injury
1%
Chronic kidney 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
Placebo Group
Group I: Faricimab injectionExperimental Treatment1 Intervention
Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The 6-mg dose of faricimab will be administered by IVT at the study site to patients. A specified filter needle must be used for each dose preparation of faricimab according to the instructions provided in the Investigator's Brochure and package insert. No other material than specified should be used. Vials of faricimab drug product are for a single-dose only (one injection preparation per patient per eye). Vials used for one patient must not be used for any other patient. Partially used vials, remaining faricimab drug product, as well as administration material must not be reused.
Group II: Sham injectionPlacebo Group1 Intervention
Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The sham procedure mimics an intravitreal injection of faricimab except that the blunt end of an empty syringe is pressed against an anesthetized eye instead of a needle attached to a faricimab-filled syringe.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,785 Previous Clinical Trials
2,779,952 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
687 Patients Enrolled for Diabetic Retinopathy
~60 spots leftby Jan 2025
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