About this trial
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
BCVA score at screening of >= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)
Collection of >= 90 micro liter (μL) AH deemed feasible and safe by the investigator.
Disqualifiers
Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.
History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.
Center-involved Diabetic Macular Edema (DME)
Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below.
Trial design
Sequential
Treatments tested in this trial
RO7663498
DrugParticipants will receive RO7663498 as per the schedule defined in the protocol.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants With Ocular Adverse Events (AEs)
Percentage of Participants With Systemic (non-ocular) AEs
Number of Abnormalities Recorded in Standard Ophthalmological Assessments
Secondary outcomes
Aqueous Humor (AH) Concentrations of RO7663498
Serum Concentrations of RO7663498
Sponsors and contacts
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