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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330. |
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| Part 1B: Syfovre and Izervay | Experimental | Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye. |
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| Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay) | Experimental | Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7669330 | Drug | RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to a maximum of 34 weeks | |
| Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments | The standard ophthalmological assessments that will be conducted may include the following: slit-lamp, indirect ophthalmology, intraocular pressure (IOP), best corrected visual acuity (BCVA), spectral domain optical coherence tomography (SD-OCT), fundus fluorescein angiography (FFA), and color fundus photography (CFP). | Up to a maximum of 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330 | Up to a maximum of Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Ocular Exclusion Criteria for the Study Eye:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants - Phoenix - DocTrials - PPDS | Phoenix | Arizona | 85020-5505 | United States | ||
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Part 1A will be a single group study, while Part 1B and Part 2 will follow a parallel-group design.
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Part 1A of the study will be open-label and non-randomized while Part 1B and 2 will be masked and randomized.
| Syfovre™ | Drug | Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms. |
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| Izervay™ | Drug | Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms. |
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| Barnet Dulaney Perkins Eye Center |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Retinal Consultants Medical Group Inc - Parkcenter Drive | Sacramento | California | 95825 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Retina Northwest | Portland | Oregon | 97221 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16505 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Texas Westover Hills Retina Center | San Antonio | Texas | 78251 | United States |
| Retina Consultants of Texas - (The Woodlands) | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
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