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This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive RO7663498. |
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| Cohort 2 | Experimental | Participants will receive RO7663498. |
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| Cohort 3 | Experimental | Participants will receive RO7663498. |
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| Cohort 4 | Experimental | Participants will receive RO7663498. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7663498 | Drug | Participants will receive RO7663498 as per the schedule defined in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ocular Adverse Events (AEs) | Up to Week 20 | |
| Percentage of Participants With Systemic (non-ocular) AEs | Up to Week 20 | |
| Number of Abnormalities Recorded in Standard Ophthalmological Assessments | Up to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous Humor (AH) Concentrations of RO7663498 | Up to Week 12 | |
| Serum Concentrations of RO7663498 | Up to Week 20 |
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Inclusion Criteria:
General Inclusion Criteria
Ocular Inclusion Criteria for the Study Eye
Exclusion Criteria:
General Exclusion Criteria:
Ocular Exclusion Criteria for the Study Eye
Ocular Exclusion Criteria for the Non-study Eye
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management | Recruiting | Glendale | California | 91204 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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