A Phase 4 interventional study of Faricimab Injection and sham treatment in Diabetic Retinopathy and Vitreous Hemorrhage Due to Diabetes Mellitus, sponsored by University of Colorado, Denver. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Supportive care
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.
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Patients must meet the following criteria for study entry:
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
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
Exclusion Criteria:
General:
Patients who meet any of the following general exclusion criteria will be excluded from study entry:
Ocular exclusion criteria for study eye:
Patients who meet any of the following exclusion criteria for the study eye will be excluded from study entry:
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.
Drug: Faricimab Injection
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.
Drug: sham treatment
Pre-operative injection of bevacizumab appears to have mixed results in lowering post-operative vitreous hemorrhage. One potential reason is due to aspiration and removal of medication in the vitreous humor at the time of pars plana vitrectomy leading to less than anticipated results in controlling neovascularization and vitreous hemorrhage post-operatively. To avoid attenuation of our desired effect we plan to repeat faricimab injection post-operatively around week one.
Also known as: Vabysmo
Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection
Rates of post-operative vitreous hemorrhage
Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated.
Time frame: 6 months
BCVA outcomes
Vision will be tested following treatment and surgery on the Snellen Chart, with or without correction as indicated.
Time frame: 6 and 12 months
Rates of re-operation for non-clearing vitreous hemorrhage
Following treatment and surgery, if re-operation for non-clearing vitreous hemorrhage is indicated, this will be track and quantified.
Time frame: 6 and 12 months
Rate of post-operative epiretinal membrane formation.
Following treatment and surgery, the duration of time if a patient was to develop an epiretinal membrane will be quantified and evaluated.
Time frame: Through study completion, an average of 1 year
Rate of post-operative rhegmatogenous or tractional retinal detachment.
Following treatment and surgery, the duration of time if a patient was to develop a rhegmatogenous or tractional retinal detachment will be quantified and evaluated.
Time frame: Through study completion, an average of 1 year
Duration of operative time.
The official duration of surgical time will be quantified and evaluated.
Time frame: intra-operatively
Number of endodiathermy use exchanges intra-operatively.
At the time of surgery, the number of endodiathermy use exchanges will be counted and evaluated.
Time frame: intra-operatively
Number of retinal breaks intra-operatively.
At the time of surgery, the number of retinal breaks intra-operatively will be counted and evaluated.
Time frame: intra-operatively
Number of patients with intra-operative bleeding
At the time of surgery, the number of patients who experience intra-operative bleeding will be counted and evaluated.
Time frame: intra-operatively
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Colorado, Denver