臨床研究等提出・公開システム

A MULTICENTER, OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

This study will evaluate the long-term safety and tolerability of intravitreal (IVT) faricimab inpatients with neovascular age-related macular degeneration (nAMD) who have completed
either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.

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

Not Recruiting

Aug. 23, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. 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 faricimab. Women must refrain from donating eggs during the same period.

Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose of faricimab
Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study-related procedure preparations, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Both

neovascular Age-related Macular Edema

Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

Safety
Incidence and Severity of Ocular Adverse Events
Incidence and Severity of Non-Ocular Adverse Events

Efficacy, Exploratory, Phamacokinetics
Change in BCVA as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
Proportion of patients avoiding loss of >= 15, >= 10 or >= 5 letters in BCVA
Proportion of patients gaining >=15, >=10, >=5, or >=0 letters in BCVA
Change in central subfield thickness (CST) as measured by optical coherence tomography (OCT)
As determined by OCT, proportion of patients with absence of central retina: Intraretinal fluid, Subretinal fluid, Both intraretinal and subretinal fluid, Intraretinal cysts, Pigment epithelial detachment
Change in total area of CNV lesion as assessed by FFA
Change in total area of leakage as assessed by FFA
Number of faricimab injections received during the LTE study
The proportion of patients on a Q8W, Q12W, and Q16W treatment interval during the study

+81-42-665-5611

May. 28, 2021

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).

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