Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose Stage | Experimental | Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D). |
|
| Expansion Cohort Stage | Experimental | Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage. |
|
| Optional Cohort E | Experimental | An optional additional cohort may be added with the dose not exceed the MTD or MTeD. |
|
| Optional cohort F | Experimental | An optional additional cohort may be added with the dose not exceed the MTD or MTeD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7303359 | Drug | RO730359 will be administered as a single intravitreal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ocular Adverse Events | Up to 12 weeks | |
| Percentage of Participants With Systemic Adverse Events | Up to 12 weeks | |
| Percentage of Participants With Dose-limiting Adverse Events (DLAEs), | Up to 12 weeks | |
| Percentage of Participants With Serious Adverse Events (SAEs) | Up to 12 weeks | |
| Percentage of Participants With Adverse Events Leading to Study Discontinuation | Up to 12 weeks | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Up to 12 weeks | |
| Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | Baseline, Week 12 |
Not provided
Not provided
Ocular Inclusion Criteria Study Eye:
Ocular Exclusion Criteria, Study Eye:
Ocular Exclusion Criteria, Both eyes:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States | ||
| Retinal Consultants Med Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40538770 | Derived | Pearlman JA, Sheth VS, Khanani AM, Indjeian VB, Brunstein F, Kuruvilla D, Maia M, Dere R, Ma L, Chen H, Datta S, Willis JR, Wiley HE. Phase I Study of the Anti-interleukin 33 Fragment Antigen-Binding Region RO7303359 in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmol Sci. 2025 Apr 20;5(5):100800. doi: 10.1016/j.xops.2025.100800. eCollection 2025 Sep-Oct. |
Not provided
Not provided
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sacramento |
| California |
| 95825 |
| United States |
| California Retina Consultants - Santa Maria | Santa Maria | California | 93454 | United States |
| Colorado Retina Associates, PC | Denver | Colorado | 80230 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 48073 | 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 |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided