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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT07425522
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
May 2026
Primary completion
Nov 17, 2028
Completion
Nov 17, 2028

Study Design

Enrollment
93 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Multiple Ascending Dose (MAD) Monotherapy
    Participants will receive multiple doses of RO7823653, administered as an IVT injection.
  • Experimental: Part 2: Optional Multiple-Dose Expansion
    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.
  • Experimental: Part 3: MAD (RO7823653 + Faricimab)
    Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.

Primary Outcome Measure

Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs [ Time Frame: Up to approximately 20 Weeks ]

Central Contacts

  • Reference Study ID Number GR46431 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]

Locations (8)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants - Peoria - DocTrials - PPDSPeoriaArizona85381-3690-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-1838-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-1141-
Erie Retina Research, LLC - 300 State StEriePennsylvania16507-1429-
Retina Research Institute of TexasAbileneTexas79606-1224-
Austin Clinical Research, LLCAustinTexas78750-2298-
Retina Consultants of Texas Westover Hills Retina CenterSan AntonioTexas78251-
Piedmont Eye CenterLynchburgVirginia24502-4271-

Find similar trials in Peoria, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Associated Retina Consultants - Peoria - DocTrials - PPDS· Peoria, AZRetina-Vitreous Associates Medical Group· Beverly Hills, CARetina Vitreous Associates of Florida· St. Petersburg, FLErie Retina Research, LLC - 300 State St· Erie, PARetina Research Institute of Texas· Abilene, TXAustin Clinical Research, LLC· Austin, TX

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