Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Colorado, Denver
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
● Patients diagnosed with non-clearing vitreous hemorrhage with or without tractional retinal detachment secondary to proliferative diabetic retinopathy and undergoing pars plana vitrectomy
You may not be if
General:
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
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)
