Diabetic Macular Edema
Conditions
Brief 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.
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.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required * Uncontrolled blood pressure * For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant. * For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant * History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye * Active intraocular inflammation in either eye * Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs | Up to approximately 20 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentrations of RO7823653 | Up to approximately 20 Weeks |
| Aqueous Humor Concentrations of RO7823653 | Up to approximately 20 Weeks |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653 | Up to approximately 20 Weeks |
| Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score | Up to approximately 20 Weeks |
| Change From Baseline in Retinal Thickness | Up to approximately 20 Weeks |
| Recommended Dose of RO7823653 | Up to approximately 20 Weeks |
Countries
United States
Contacts
CONTACTReference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed