NCT07425522

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	RO7823653	Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
DRUG	Faricimab	Participants will receive faricimab as an IVT injection per the schedule described in the protocol.

Timeline

• Start date: 2026-04-22
• Primary completion: 2028-11-17
• Completion: 2028-11-17
• First posted: 2026-02-23
• Last updated: 2026-04-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study