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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 below

Select...

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

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 2023 Phase 3 trial • 1479 Patients • NCT04432831

10%

COVID-19

Cataract

Diabetic retinal oedema

Posterior capsule opacification

Hypertension

Urinary tract infection

Pneumonia

Conjunctival haemorrhage

Intraocular pressure increased

Diabetic retinopathy

Vitreous detachment

Nasopharyngitis

Cardiac failure

Nephrolithiasis

Vitreous haemorrhage

Death

Acute myocardial infarction

Cardiac failure congestive

Myocardial infarction

Cellulitis

Osteomyelitis

Cerebrovascular accident

Acute kidney injury

Chronic kidney disease

Diabetic foot

Vitreous floaters

Peripheral ischaemia

Coronary artery disease

Breast cancer

100%

80%

60%

40%

20%

Study treatment Arm

Faricimab PTI (Prior Faricimab PTI)

Faricimab PTI (Prior Faricimab Q8W)

Faricimab PTI (Prior Aflibercept Q8W)

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.

0 / 2Eligibility criteria met