Palmetto Retina Center | West Columbia, SC
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About
The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy.
Full description
Group 1: Subjects will be administered intravitreal faricimab every 4 through week 48 and then will be receive faricimab every 16 weeks with an end of study visit at week 96. At any visit after Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.
Group 2: Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab every 4 weeks from week 48 to week 92 with an end of study visit at week 96. At any visit before Week 48, if rescue criteria are met, faricimab will be given every 4 weeks and the subject will continue dosing through the end of the trial.
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Inclusion criteria
Contraception methods that do not result in a failure rate of < 1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable.
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 subject. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements of the study.
Ocular inclusion criteria for study eye:
Subjects must meet the following ocular inclusion criteria for the study eye for entry into the study:
Exclusion criteria
Any known hypersensitivity to any of the components in the faricimab injection
Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the site during the study
Active cancer within the past 12 months prior to Screen/Baseline except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for >12 months
Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Screen/Baseline
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
o Women of childbearing potential must have a negative urine pregnancy test at the Screen/Baseline visit for both Group 1 and Group 2. Women of childbearing potential must also have a negative urine pregnancy test on any visit where they will receive treatment with IP or rescue medication. Urine pregnancy tests must be completed prior to the administration of IP/rescue medication and prior to FA being performed.
Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Screen/Baseline, or during the course of this study
Any prior or concomitant systemic anti-VEGF treatment within 4 months prior to Screen/Baseline
Any use of any prohibited therapies during times of prohibition.
Ocular exclusion criteria for study eye:
Subjects who meet any of the following exclusion criteria for the study eye will be excluded from study entry:
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Central trial contact
Cassie Cone; Patrice Brock
Data sourced from clinicaltrials.gov
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