Phase 1: testing RO7823653 for Diabetic Macular Edema
This study wants to measure the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as this drug alone and co-administered with faricimab.
Official registry: https://clinicaltrials.gov/study/NCT07425522 · Genentech, Inc. · enrollment listed as 93
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are RO7823653, or Faricimab. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as this drug alone and co-administered with faricimab.
They plan to enroll about 93 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: RO7823653, Faricimab
Primary outcome (registry wording): Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
12 listed- Associated Retina Consultants - Peoria - DocTrials - PPDS — Peoria, Arizona (recruiting)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California (recruiting)
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS — Walnut Creek, California (recruiting)
- Retina Vitreous Associates of Florida — St. Petersburg, Florida (recruiting)
- Wilmer Eye Institute — Baltimore, Maryland (recruiting)
- Erie Retina Research, LLC - 300 State St — Erie, Pennsylvania (recruiting)
- Wills Eye Hospital — Philadelphia, Pennsylvania (recruiting)
- Charles Retina Institute — Germantown, Tennessee (recruiting)
- Retina Research Institute of Texas — Abilene, Texas (recruiting)
- Austin Clinical Research, LLC — Austin, Texas (recruiting)
- Retina Consultants of Texas Westover Hills Retina Center — San Antonio, Texas (recruiting)
- Piedmont Eye Center — Lynchburg, Virginia (recruiting)
FAQ about this NCT record
Is NCT07425522 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07425522?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07425522?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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