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A PHASE IIIb/IV, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF FARICIMAB (RO6867461) IN PATIENTS WITH POLYPOIDAL CHOROIDAL VASCULOPATHY

A Study to Investigate the Efficacy and Safety of Faricimab in Patients with Polypoidal Choroidal Vasculopathy

Nitin Jain, M.D.

F. Hoffmann-La Roche Ltd

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Complete

Nov. 15, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
Confirmed diagnosis, by the investigator, of symptomatic macular PCV
BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing
distance of 4 meters on study Day 1
For female participants of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year, during the treatment period and for 38 days after the final dose of faricimab

Any major illness or major surgical procedure within 1 month before screening
Continuous use of any medications and treatments indicated in Prohibited Therapy
Uncontrolled blood pressure on study Day 1
History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 38 days after the final dose of faricimab
Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia (For participants who have undergone prior refractive or cataract surgery, the preoperative refractive error should not have exceeded -8 diopters of myopia.)
Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1
Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases
Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention
Uncontrolled glaucoma

Both

POLYPOIDAL CHOROIDAL VASCULOPATHY

faricimab: 6.0 mg of faricimab (genetical recombination) is administered by intravitreal injection once every 4-20 weeks.

Efficacy
Change from baseline in BCVA based on an average at Weeks 40, 44, and 48

Safety, Efficacy, Other
Change from baseline in BCVA based on an average at Weeks 100, 104, and 108
Change from baseline in BCVA over time and proportion of participants gaining / avoiding loss of >= 15, >= 10, or >= 5 letters in BCVA from baseline over time
Proportion of participants with complete polypoidal lesion regressions at Weeks 16, 48, and 108
Change from baseline in CST based on an average at Weeks 40, 44, 48, 100, 104 and 108
Change from baseline in CST over time
Proportion of participants on a Q8W, Q12W, and Q16W treatment interval at Weeks 24, 44, and 108, and Q20W at Week 108
Number of faricimab injections received from Week 48 through Week 108
Incidence and severity of adverse events

+81-29-246-2111

April. 13, 2022

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

China/Hong Kong/Singapore/Taiwan/Malaysia/South Korea/Thailand/India