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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001972-40 | EudraCT Number |
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This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: RO6867461 | Experimental | Single doses |
|
| Part B: RO6867461 | Experimental | Multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO6867461 | Drug | Single or multiple ascending dose by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography | Part A, 12 weeks; Part B, 20 weeks | |
| Safety: Incidence of adverse events | Part A, 12 weeks; Part B, 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration time curve (AUC) | Part A, 12 weeks; Part B, 20 weeks | |
| Pharmacokinetics: Maximum plasma concentration (Cmax) | Part A, 12 weeks; Part B, 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Springs | Colorado | 80909 | United States | |||
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77030 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Belfast | BT12 6BA | United Kingdom |
| Bristol | BS1 2LX | United Kingdom |
| London | EC1V 2PD | United Kingdom |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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