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

Purpose

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.

Condition

  • Diabetic Macular Edema

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Multiple Ascending Dose (MAD) Monotherapy 		Participants will receive multiple doses of RO7823653, administered as an IVT injection.
  • Drug: RO7823653
    Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
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.
  • Drug: RO7823653
    Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
Experimental
Part 3: MAD (RO7823653 + Faricimab) 		Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.
  • 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.

Recruiting Locations

Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria, Arizona 85381-3690

Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211-1838

Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711-1141

Erie Retina Research, LLC - 300 State St
Erie, Pennsylvania 16507-1429

Retina Research Institute of Texas
Abilene, Texas 79606-1224

Austin Clinical Research, LLC
Austin, Texas 78750-2298

Retina Consultants of Texas Westover Hills Retina Center
San Antonio, Texas 78251

Piedmont Eye Center
Lynchburg, Virginia 24502-4271

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number GR46431 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com