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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Phoenix 5308655, Arizona 5551752 85020-5505
Sun City 5316201, Arizona 5551752 85351
Beverly Hills 5328041, California 5332921 90211
Glendale 5352423, California 5332921 91204
Sacramento 5389489, California 5332921 95825
Augusta 4180531, Georgia 4197000 30909
Hagerstown 4357141, Maryland 4361885 21740
St Louis 4407066, Missouri 4398678 63128
Portland 5746545, Oregon 5744337 97221
Erie 5188843, Pennsylvania 6254927 16505
Germantown 4624601, Tennessee 4662168 38138
Nashville 4644585, Tennessee 4662168 37203
Austin 4671654, Texas 4736286 78750
Dallas 4684888, Texas 4736286 75231
San Antonio 4726206, Texas 4736286 78251
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