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This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7171009: SAD | Experimental | Patients will receive a single dose of RO7171009, in multiple escalating cohorts. |
|
| RO7171009: MD | Experimental | Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7171009 | Drug | Patients will receive RO7171009 via ITV injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of the Study Drug: Rate of Adverse Events | Through study completion or early study discontinuation (overall 12-20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of RO7171009 | Through study completion or early study discontinuation (overall 12-20 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Ocular Exclusion Criteria, Study Eye:
Ocular Exclusion Criteria (Both Eyes):
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| Northern California Retina Vitreous Associates |
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| Mountain View |
| California |
| 94040 |
| United States |
| Retinal Consultants Med Group | Sacramento | California | 95825 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| California Retina Consultants - Santa Maria | Santa Maria | California | 93454 | United States |
| Retina Consultants of Southern Colorado PC; Clinical Research Department | Colorado Springs | Colorado | 80909-1183 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Georgia Retina PC | Marietta | Georgia | 30060 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | United States |
| Tennessee Retina PC. | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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