A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab

Inclusion Criteria

• Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association
• Hemoglobin A1c (HbA1c) ≤10%
• Patients who are intravitreal (IVT) treatment-naïve in the study eye
• Diabetic macular edema (DME) defined as macular thickening by spectral-domain optical coherence tomography (SD-OCT) involving the center of the macula. This inclusion criterion is to be assessed by the central reading center (CRC).
• Decreased visual acuity (VA) attributable primarily to DME
• Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

Exclusion Criteria

• Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
• Any known hypersensitivity to any of the components in the faricimab injection, dilating eye drops, or any of the anesthetics and antimicrobial preparations used by the patient during the study
• Any major illness or major surgical procedure within 1 month before the Day 1. One re-screening for this criterion is permitted
• History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the Investigator
• Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for >12 months
• Stroke or myocardial infarction within 12 months prior to the Day 1. One re-screening for this criterion is permitted
• Any febrile illness within 1 week prior to Day 1. One re-screening for this criterion is permitted
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
• Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
• Any condition resulting in a compromised immune system that is likely to impact the aqueous humor (AH) inflammatory biomarkers.
• Patients who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within 3 months or 5 half-lives prior to Day 1 and up to completion of the current study
• Substance abuse occurring within 12 months prior to screening, in the Investigator's judgment
• Use of systemic immunomodulatory treatments within 6 months or 5 half-lives prior to Day 1
• Use of any systemic corticosteroids (including inhaled corticosteroids from inhalers used regularly, e.g., pulmonary disease, asthma, or seasonal allergy) within 1 month prior to Day 1
• Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives prior to Day 1
• Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-month period or 5 half-lives prior to Day 1 or likely need to be used
• Received a blood transfusion within 3 months prior to the screening visit
• Received any treatment that leads to immunosuppression within 6 months or 5 half-lives prior to Day 1

Ocular Exclusion Criteria for Study Eye:

• High-risk PDR. This exclusion criterion is to be assessed by the CRC
• Any history of or ongoing rubeosis iridis
• Any panretinal photocoagulation or macular laser photocoagulation treatment received in the study eye prior to the screening visit or expected to be received between the screening visit and Day 1
• Any hist