Japan phase I Study of RO6867461

A phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6867461 (RG7716) Following Intravitreal Administration in Japanese Patients with Wet Age-Related Macular Degeneration and Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223578

Enrollment

Registered

2017-06-28

Start date

2017-08-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wet age-related macular degeneration (wAMD) or diabetic macular edema (DME)

Interventions

investigational material(s) Generic name etc : RO6867461 INN of investigational material : Faricimab Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
safety Safety, Tolerability Observation / inspection	—

Secondary

Measure	Time frame
pharmacokinetics Pharmacokinetics Observation / inspection	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026