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Recruiting NCT07425522

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

Phase I Interventional Diabetic Macular Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RO7823653, Faricimab.
Who it may be relevant to
Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug RO7823653
    Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
  • Drug Faricimab
    Participants will receive faricimab as an IVT injection per the schedule described in the protocol.

Primary outcome measures

  • Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs [Time frame: Up to approximately 20 Weeks]
Secondary outcome measures (6)
  • Serum Concentrations of RO7823653 [Time frame: Up to approximately 20 Weeks]
  • Aqueous Humor Concentrations of RO7823653 [Time frame: Up to approximately 20 Weeks]
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653 [Time frame: Up to approximately 20 Weeks]
  • Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score [Time frame: Up to approximately 20 Weeks]
  • Change From Baseline in Retinal Thickness [Time frame: Up to approximately 20 Weeks]
  • Recommended Dose of RO7823653 [Time frame: Up to approximately 20 Weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Associated Retina Consultants - Peoria - DocTrials - PPDS — Peoria
  • Retina-Vitreous Associates Medical Group — Beverly Hills
  • Bay Area Retina Specialists Medical Group - Vestrum - PPDS — Walnut Creek
  • Retina Vitreous Associates of Florida — St. Petersburg
  • Erie Retina Research, LLC - 300 State St — Erie
  • Charles Retina Institute — Germantown
  • Retina Research Institute of Texas — Abilene
  • Austin Clinical Research, LLC — Austin
  • … and 2 more centers

Identifiers

NCT: NCT07425522 · GR46431

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗