Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06191094
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Faricimab Injection — DRUG
    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.
  • sham treatment — DRUG
    Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection

Study Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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 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.
  • Sham Comparator: Sham 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.

Primary Outcome Measure

Rates of post-operative vitreous hemorrhage [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sue Anschutz-Rodgers Eye CenterAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Sue Anschutz-Rodgers Eye Center· Aurora, CO

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