Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615325
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2020-10-29
Brief Title:
A Study Evaluating the Safety Tolerability Pharmacokinetics and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase 1a Multicenter Open-label Single-dose Dose-escalation Study of the Safety Tolerability Pharmacokinetics and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None