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)

Purpose

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.

Conditions

  • Geographic Atrophy
  • Age-related Macular Degeneration

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adequately clear ocular media, adequate pupillary dilation, and fixation to allow acquisition of good quality fundus imaging - GA that resides completely within the fundus autofluorescence (FAF) imaging field - Presence of hyperautofluorescence of either banded or diffuse pattern adjacent to the GA area on FAF - Study eye has early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) score as follows: - Part 1A: 19 to 48 letters, inclusively - Part 1B: > 19 letters - Part 2: ≥ 24 letters - Total GA lesion size must be as follows: - Parts 1A and 1B: ≥ 1.25 square millimeter (mm^2) and ≤ 20 mm^2 ) - Part 2: ≥ 2.5 mm^2 and ≤ 20 mm^2

Exclusion Criteria

Ocular Exclusion Criteria for the Study Eye: - Aphakic or pseudophakic with intraocular lens outside of the capsular bag - Previous laser photocoagulation or IVT anti-vascular endothelial growth factor (VEGF) for CNV, diabetic macular edema (DME), retinal vein occlusion (RVO), or proliferative diabetic retinopathy - Active or history of CNV Ocular Exclusion Criteria for the Non-Study Eye: - Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye Ocular Exclusion Criteria for Both Eyes: - Macular atrophy in either eye due to causes other than AMD - Part 2: Evidence of prior or active CNV - Prior treatment with any approved therapy for GA (Syfovre, Izervay) in either eye for Part 1A and Part 2 ≤ 20 weeks prior to Day 1. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part 1A will be a single group study, while Part 1B and Part 2 will follow a parallel-group design.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Part 1A of the study will be open-label and non-randomized while Part 1B and 2 will be masked and randomized.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: RO7669330
    RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
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.
  • Drug: Syfovre™
    Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
    Other names:
    • Pegcetacoplan injection
  • Drug: Izervay™
    Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
    Other names:
    • Avacincaptad pegol IVT solution
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.
  • Drug: RO7669330
    RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
  • Drug: Syfovre™
    Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
    Other names:
    • Pegcetacoplan injection
  • Drug: Izervay™
    Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
    Other names:
    • Avacincaptad pegol IVT solution

Recruiting Locations

Associated Retina Consultants - Phoenix - DocTrials - PPDS
Phoenix 5308655, Arizona 5551752 85020-5505

Barnet Dulaney Perkins Eye Center
Sun City 5316201, Arizona 5551752 85351

Retina-Vitreous Associates Medical Group
Beverly Hills 5328041, California 5332921 90211

Global Research Management
Glendale 5352423, California 5332921 91204

Retinal Consultants Medical Group Inc - Parkcenter Drive
Sacramento 5389489, California 5332921 95825

Southeast Retina Center
Augusta 4180531, Georgia 4197000 30909

Cumberland Valley Retina Consultants PC
Hagerstown 4357141, Maryland 4361885 21740

The Retina Institute
St Louis 4407066, Missouri 4398678 63128

Retina Northwest
Portland 5746545, Oregon 5744337 97221

Erie Retina Research
Erie 5188843, Pennsylvania 6254927 16505

Charles Retina Institute
Germantown 4624601, Tennessee 4662168 38138

Tennessee Retina PC
Nashville 4644585, Tennessee 4662168 37203

Austin Clinical Research, LLC
Austin 4671654, Texas 4736286 78750

Texas Retina Associates
Dallas 4684888, Texas 4736286 75231

Retina Consultants of Texas Westover Hills Retina Center
San Antonio 4726206, Texas 4736286 78251

Retina Consultants of Texas - (The Woodlands)
The Woodlands 4736476, Texas 4736286 77384

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP45482 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com