Phase 1 Evaluation of RO7823653 Injection Alone and Combined with Faricimab for Diabetic Macular Edema

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacodynamics PD, and pharmacokinetics PK of multiple doses of RO7823653 in adults with diabetic macular edema DME. This is a Phase 1 study focused on administering RO7823653 alone and in combination with faricimab via intravitreal IVT injection. The purpose is to understand how these treatments behave in the eye and body and their safety profiles. Participants receive multiple doses of RO7823653 as IVT injections either alone or combined with faricimab. The study includes a sequential design with different parts a multiple ascending dose MAD monotherapy stage, an optional multiple-dose expansion, and a combination therapy stage with faricimab. Doses are given at or below the maximum tolerated or tested dose determined during the MAD stage. During the study, participants will be monitored for ocular and systemic adverse events up to about 20 weeks. Researchers will measure serum and eye fluid concentrations of RO7823653, anti-drug antibody presence, changes in visual acuity, and retinal thickness. The study assesses the recommended dose of RO7823653 and includes safety and pharmacological evaluations throughout the treatment period.

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