A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
Genentech, Inc.
Summary
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association * Glycated hemoglobin (HbA1c) \<= 12% * For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters Exclusion Criteria: * Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1 * Pregnant or br…
Interventions
- DrugRO7823653
Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
- DrugFaricimab
Participants will receive faricimab as an IVT injection per the schedule described in the protocol.
Locations (8)
- Associated Retina Consultants - Peoria - DocTrials - PPDSPeoria, Arizona
- Retina-Vitreous Associates Medical GroupBeverly Hills, California
- Retina Vitreous Associates of FloridaSt. Petersburg, Florida
- Erie Retina Research, LLC - 300 State StErie, Pennsylvania
- Retina Research Institute of TexasAbilene, Texas
- Austin Clinical Research, LLCAustin, Texas