Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550011
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of Intravitreal IVT Injection of ABI-110 AAV2N54-VEGF Trap in Subjects With Neovascular Wet Age-Related Macular Degeneration wAMD Including Symptomatic Macular Polypoidal Choroidal Vasculopathy PCV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12a Open-Label Multiple-Cohort Dose-Escalation Study to Evaluate the Safety Tolerability and Preliminary Efficacy of Intravitreal IVT Injection of ABI-110 AAV2N54- VEGF Trap in Subjects With Neovascular Wet Age-Related Macular Degeneration wAMD Including Symptomatic Macular Polypoidal Choroidal Vasculopathy PCV
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration wAMD including symptomatic macular PCV
Detailed Description:
This is a Phase 12a open-label multiple-cohort dose-escalation study to evaluate the safety tolerability and preliminary efficacy of IVT ABI-110 AAV2N54-VEGF-Trap injection in subjects with wAMD including symptomatic macular PCV
This trial will include a screening period confirmation of response to EYLEA aflibercept single administration of ABI-110 and follow-up period of 104 weeks after IVT ABI-110 injection
This trial will include a screening period confirmation of response to EYLEA aflibercept single administration of ABI-110 and follow-up period of 104 weeks after IVT ABI-110 injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None