Vabysmo for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Patients must meet the following criteria for study entry: Signed Informed Consent Form, Age ≥ 18 years at time of signing Informed Consent Form, Ability to comply with the study protocol, For women of childbearing potential: agreement to remain abstinent or use contraception with a failure rate of <1% per year during the treatment period and for 3 months after the final dose of the study drug. Examples of acceptable contraceptive methods provided.

I have a severe eye condition due to diabetes and need surgery.

Exclusion Criteria

General exclusion criteria: Known hypersensitivity to components in the faricimab injection, dilating eye drops, disinfectants, anesthetics, or antimicrobial preparations used during the study, History of diseases or conditions contraindicating the use of faricimab, Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab. Women of childbearing potential must have negative pregnancy tests at specified time points.

My study eye has not had recent treatments or surgeries, and only has diabetic retinopathy.

Participant Groups

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.

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.

Faricimab is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vabysmo for: