RO7823653 for Diabetic Macular Edema

Recruiting at 7 trial locations

Overseen By Reference Study ID Number GR46431 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Untreated diabetes, Uncontrolled blood pressure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Glycated hemoglobin (HbA1c) <= 12%

I have been diagnosed with diabetes (type 1 or type 2).

My eye has center-involving DME with significant swelling and moderate vision loss.

Exclusion Criteria

I have diabetes that is untreated or was just started on medication in the last 90 days.

History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye

Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Monotherapy

Participants receive multiple doses of RO7823653 administered as an intravitreal injection

8-12 weeks

Treatment - Combination Therapy

Participants receive multiple doses of RO7823653 along with faricimab, administered as an intravitreal injection

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Faricimab
• RO7823653

How Is the Trial Designed?

Group I: Part 3: MAD (RO7823653 + Faricimab) Experimental Treatment 2 Interventions

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

Group II: Part 2: Optional Multiple-Dose Expansion Experimental Treatment 1 Intervention

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.

Group III: Part 1: Multiple Ascending Dose (MAD) Monotherapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD