A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT06961370
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • RO7669330 — DRUG
    RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
  • Syfovre™ — DRUG
    Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
  • Izervay™ — DRUG
    Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Study Details

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in participants with GA secondary to AMD in at least one eye in Part 1, or both eyes in Part 2, after multiple unilateral intravitreal (IVT) doses.

Key Dates

Start date
Jul 16, 2025
Status verified
May 2026
Primary completion
Jan 3, 2027
Completion
Jan 3, 2027

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Multiple Ascending Dose (MAD)
    Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
  • Experimental: Part 1B: Syfovre and Izervay
    Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
  • Experimental: Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
    Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to a maximum of 34 weeks ]

Locations (16)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants - Phoenix - DocTrials - PPDSPhoenixArizona85020-5505-
Barnet Dulaney Perkins Eye CenterSun CityArizona85351-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Global Research ManagementGlendaleCalifornia91204-
Retinal Consultants Medical Group Inc - Parkcenter DriveSacramentoCalifornia95825-
Southeast Retina CenterAugustaGeorgia30909-
Cumberland Valley Retina Consultants PCHagerstownMaryland21740-
The Retina InstituteSt LouisMissouri63128-
Retina NorthwestPortlandOregon97221-
Erie Retina ResearchEriePennsylvania16505-
Charles Retina InstituteGermantownTennessee38138-
Tennessee Retina PCNashvilleTennessee37203-
Austin Clinical Research, LLCAustinTexas78750-
Texas Retina AssociatesDallasTexas75231-
Retina Consultants of Texas Westover Hills Retina CenterSan AntonioTexas78251-
Retina Consultants of Texas - (The Woodlands)The WoodlandsTexas77384-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Associated Retina Consultants - Phoenix - DocTrials - PPDS· Phoenix, AZBarnet Dulaney Perkins Eye Center· Sun City, AZRetina-Vitreous Associates Medical Group· Beverly Hills, CAGlobal Research Management· Glendale, CARetinal Consultants Medical Group Inc - Parkcenter Drive· Sacramento, CASoutheast Retina Center· Augusta, GA

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