Health TrialsbyHealthPanel

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

ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RO7823653

    Drug

    Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.

  • Faricimab

    Drug

    Participants will receive faricimab as an IVT injection per the schedule described in the protocol.

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Part 1: Multiple Ascending Dose (MAD) MonotherapyExperimental treatment 1 intervention
Group B: Part 2: Optional Multiple-Dose ExpansionExperimental treatment 1 intervention
Group C: Part 3: MAD (RO7823653 + Faricimab)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs

Time frame
Up to approximately 20 Weeks

Secondary outcomes

1

Serum Concentrations of RO7823653

Time frame
Up to approximately 20 Weeks
2

Aqueous Humor Concentrations of RO7823653

Time frame
Up to approximately 20 Weeks
3

Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653

Time frame
Up to approximately 20 Weeks
4

Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score

Time frame
Up to approximately 20 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now