Japan phase I Study of RO6867461

JRCT ID: jRCT2080223578

Registered date:28/06/2017

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: wet age-related macular degeneration (wAMD) or diabetic macular edema (DME)
• Date of first enrollment: 10/08/2017
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : RO6867461
INN of investigational material : Faricimab
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : IVT administration of either 1.5 mg or 6 mg dose every 4 weeks(3 doses)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
Safety, Tolerability

Observation / inspection

Secondary Outcome

pharmacokinetics
Pharmacokinetics

Observation / inspection

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 84age old
• Gender: Both

Include criteria

[for wAMD patients]
- 50 <= Age < 85 years at consent
- Patients with wAMD
- Evidence of leakage due to choroidal neovascularization (CNV)
- Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

[for DME patients]
- 20 <= Age < 85 years at consent
- Diagnosis of diabetes mellitus (DM; Type 1 or Type 2)
- Macular edema associated with Diabetic Retinopathy defined as macular thickening by SD-OCT or SS-OCT involving the center of the macula
- Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

Exclude criteria

- Any major illness(i.e, hepatic, gastrointestinal, hematologic, immunological, neurological, pulmonary, or thyroidal disease) within 28 days prior to the screening examination
- Any stroke or myocardial infarction within 12 months prior to Day 1
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Related Information

• Primary Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-173634