Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903794
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-06-06
Brief Title:
A Study of EXG102-031 in Patients With wAMD Everest
Sponsor:
Exegenesis Bio
Organization:
Exegenesis Bio
Study Overview
Official Title:
An Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Gene Therapy With EXG102-031 in Participants With Neovascular Age-related Macular Degeneration
Status:
RECRUITING
Status Verified Date:
2024-09
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:
In neovascular wet age-related macular degeneration nAMD the macula or the part of the eye that provides the clear detailed central vision is being affected by abnormal blood vessel growth and leakage This leakage affects the vision over time and can lead to severe blurriness or blinding EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision Before EXG102-031 can be tested for its efficacy if it makes vision better it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD
Detailed Description:
Age-related macular degeneration AMD is a major cause of blindness and visual impairment in older adults The wet form of AMD also called neovascular AMD nAMD usually causes faster vision loss than the dry form The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor VEGF including ranibizumab LUCENTIS Genentech and aflibercept EYLEA Regeneron and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely This Phase I open-label multiple-cohort dose-escalation study is designed to evaluate the safety and tolerability of EXG102-031 gene therapy in subjects with previously treated nAMD Safety will be assessed over 52 weeks after the administration of EXG102-031
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