A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Genentech

Status and phase: Enrolling; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Drug: Faricimab; Drug: RO7823653

Study type: Interventional

Funder types: Industry

Identifiers

NCT07425522

GR46431

Details and patient eligibility

About

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.

Enrollment: 93 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Part 1: Multiple Ascending Dose (MAD) Monotherapy

Experimental group

Description:

Participants will receive multiple doses of RO7823653, administered as an IVT injection.

Treatment:

Drug: RO7823653

Part 2: Optional Multiple-Dose Expansion

Experimental group

Description:

Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage.

Treatment:

Drug: RO7823653

Part 3: MAD (RO7823653 + Faricimab)

Experimental group

Description:

Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.

Treatment:

Drug: RO7823653

Drug: Faricimab