a study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion

Conditions: Macular Edema; Central Retinal Vein Occlusion; Hemiretinal Vein Occlusion

Summary: this is a phase iii, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (ivt) injection at 4-week intervals until week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (pti) dosing regimen in patients with macular edema due to central retinal vein occlusion (crvo) or hemiretinal vein occlusion (hrvo).


Eligibility criteria:
inclusion criteria: * foveal center-involved macular edema due to central retinal vein occlusion (crvo) or hemiretinal vein occlusion (hrvo), diagnosed no longer than 4 months prior to the screening visit * best-corrected visual acuity (bcva) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate snellen equivalent) * sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis * for women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment exclusion criteria: * any major illness or major surgical procedure within 1 month before screening * uncontrolled blood pressure * stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to day 1 * pregnant or breastfeeding, or intending to become pregnant during the study ocular exclusion criteria for study eye: * history of previous episodes of macular edema due to rvo or persistent macular edema due to rvo diagnosed more than 4 months before screening * any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to rvo in the study eye (e.g., ischemic maculopathy, irvine-gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions) * macular laser (focal/grid) in the study eye at any time prior to day 1 * panretinal photocoagulation in the study eye within 3 months prior to day 1 or anticipated within 3 months of study start on day 1 * any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (dme) and neovascular age-related macular degeneration (namd); and vitreomacular-interface abnormalities, including, but not restricted to, ivt treatment with anti-vegf, steroids, tissue plasminogen activator, ocriplasmin, c3f8, air or periocular injection * any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy * any prior steroid implant use including dexamethasone intravitreal implant (ozurdex) and fluocinolone acetonide intravitreal implant (iluvien) ocular exclusion criteria for both eyes: * prior ivt administration of faricimab in either eye * history of idiopathic or autoimmune-associated uveitis in either eye * active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on day 1

Keywords: crvo hrvo