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

Launched by UNIVERSITY OF COLORADO, DENVER · Dec 19, 2023

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ClinConnect Summary

This phase IV study tests whether giving the drug faricimab (brand name Vabysmo) around the time of a specific eye surgery (pars plana vitrectomy) for non-clearing vitreous hemorrhage due to proliferative diabetic retinopathy can reduce postoperative problems. Participants are randomly assigned to receive either faricimab or a sham procedure, and the injection is given into the eye at the time of surgery, with a planned second dose about one week after surgery. The main goal is to see if faricimab lowers the rate of new vitreous hemorrhage within 6 months after surgery, with additional follow-up to assess vision and other eye health issues for up to about a year. The study is being conducted at the University of Colorado, Denver, and aims to enroll about 100 adults.

Who can participate: adults 18 and older who have non-clearing vitreous hemorrhage from diabetic retinopathy and are undergoing pars plana vitrectomy. You must be able to consent and follow the study plan. Women of childbearing potential must use contraception or abstain during the study and for a short time after. Exclusion criteria include allergy to faricimab or similar drugs, recent anti-VEGF treatment in the study eye, certain eye conditions, pregnancy, or other factors that could affect safety or results. If enrolled, you’ll be randomly assigned to faricimab or sham, and researchers will track outcomes such as vision, any need for additional eye surgery, and other eye complications for up to about one year. This trial is sponsored by the University of Colorado, Denver and is currently enrolling by invitation.

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Eligibility criteria

• 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, in the investigator's judgment
• * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
• • Women must remain abstinent or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for 3 months after the final dose of the study drug.
• • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
• • Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
• 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:
• • Any known hypersensitivity to any of the components in the faricimab injection
• • Any known hypersensitivity to any dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used during the study
• • History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the investigator
• • 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 a negative urine pregnancy test result at baseline prior to initiation of dosing of faricimab/sham and a negative urine pregnancy test at post-op Week 1 prior to dosing of faricimab/sham
• 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:
• • Any ocular anti-VEGF treatment within 3 months prior to Day 1 (Baseline) in the study eye
• • Vitreous hemorrhage or tractional retinal detachment suspected due to cause other than diabetic retinopathy
• • Any glaucoma surgery in the study eye prior to the Day 1 (Baseline) visit
• • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy in study eye
• • Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as intraocular pressure (IOP) ≥25 mmHg at the Day 1 (Baseline) visit despite treatment with anti-glaucoma medication)
• • Any history of idiopathic, infectious, or noninfectious uveitis
• • Any current or history of ocular disease other than diabetic retinopathy that may confound assessment of the macula or affect central vision (e.g., age-related macular degeneration, retinal vein occlusion, angioid streaks, histoplasmosis, active or inactive cytomegalovirus retinitis, pathological myopia, retinal detachment, macular traction, retinal embolus, macular hole)