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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

NCT04740931

CompletedPhase 3

Sponsor: Hoffmann-La Roche

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

Interventions: Faricimab, Aflibercept, Sham Procedure

Countries: United States, Argentina, Australia, Austria, Brazil, China, Czechia, France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (194)
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Campbell, California, United States
  • Encino, California, United States
  • Fullerton, California, United States
  • Mountain View, California, United States
  • Oakland, California, United States
  • Pasadena, California, United States
  • Poway, California, United States
  • San Francisco, California, United States
  • Colorado Springs, Colorado, United States
  • Lakewood, Colorado, United States
  • Waterford, Connecticut, United States
  • Deerfield Beach, Florida, United States
  • Deerfield Beach, Florida, United States
  • Melbourne, Florida, United States
  • Plantation, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Augusta, Georgia, United States
  • Marietta, Georgia, United States
  • ‘Aiea, Hawaii, United States
  • Chicago, Illinois, United States
  • Elmhurst, Illinois, United States
  • Oak Forest, Illinois, United States
  • Springfield, Illinois, United States
  • Lenexa, Kansas, United States
  • Baltimore, Maryland, United States
  • Chevy Chase, Maryland, United States
  • + 164 more on CT.gov