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.
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Parts 1-5: Percentage of Participants With Adverse Events (AEs)
Timeframe: From study start through end of study (Up to approximately 58 months)
Parts 1-5: Percentage of Participants With Ocular AEs
Timeframe: From study start through end of study (Up to approximately 58 months)
Part 1: Change in Best Corrected Visual Acuity (BCVA) Over Time
Timeframe: From Baseline up to Week 16
Parts 2-4: Change in BCVA Over Time
Timeframe: From Baseline up to Week 28
Part 5: Change From Baseline in BCVA Averaged Over Weeks 52 and 56
Timeframe: From Baseline up to Week 56