NCT06850922

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 546 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	RO7446603	Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
DRUG	Aflibercept	Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
DRUG	Faricimab	Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.

Timeline

• Start date: 2022-06-22
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-02-28
• Last updated: 2026-03-30

Locations

78 sites across 3 countries: United States, China, Puerto Rico

Regulatory

• FDA-regulated drug study