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Monoclonal Antibodies
Vabysmo 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
Ocular inclusion criteria for study eye: Patients diagnosed with non-clearing vitreous hemorrhage with or without tractional retinal detachment secondary to proliferative diabetic retinopathy and undergoing pars plana vitrectomy
Be older than 18 years old
Must not have
Ocular exclusion criteria for study eye: Recent ocular anti-VEGF treatment, Vitreous hemorrhage or tractional retinal detachment suspected due to causes other than diabetic retinopathy, Glaucoma surgery in the study eye, History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy in study eye, Uncontrolled glaucoma, History of uveitis, Current or history of ocular diseases other than diabetic retinopathy that may confound assessment of the macula or affect central vision.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to see if a new medication, faricimab (Vabysmo), can help reduce complications during eye surgery for diabetic patients.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a severe eye condition due to diabetes and need surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My study eye has not had recent treatments or surgeries, and only has diabetic retinopathy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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 moreSide effects data
From 2023 Phase 3 trial • 1479 Patients • NCT0443283113%
COVID-19
11%
Cataract
4%
Diabetic retinal oedema
4%
Nasopharyngitis
4%
Hypertension
3%
Conjunctival haemorrhage
3%
Intraocular pressure increased
3%
Urinary tract infection
3%
Vitreous floaters
3%
Posterior capsule opacification
3%
Diabetic retinopathy
3%
Vitreous detachment
2%
Myocardial infarction
2%
Acute kidney injury
1%
Pneumonia
1%
Cardiac failure congestive
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Localised infection
1%
Skin ulcer
1%
Osteomyelitis
1%
Vitreous haemorrhage
1%
Death
1%
Coronary artery disease
1%
Sepsis
1%
Cerebrovascular accident
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Faricimab PTI (Prior Faricimab Q8W)
Faricimab PTI (Prior Aflibercept Q8W)
Faricimab PTI (Prior Faricimab PTI)
Awards & Highlights
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.
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
1,810 Previous Clinical Trials
2,920,000 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
687 Patients Enrolled for Diabetic Retinopathy