Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07425522

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Associated Retina Consultants - Peoria - DocTrials - PPDS, Peoria, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

  5. Change From Baseline in Retinal Thickness

    Time frame: Up to approximately 20 Weeks

  6. Recommended Dose of RO7823653

    Time frame: Up to approximately 20 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.