Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776031
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2021-02-25
Brief Title:
Evaluation of RGEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes
Sponsor:
Lutronic Vision Inc
Organization:
Lutronic Vision Inc
Study Overview
Official Title:
Evaluation of the RGEN Laser System as an Intervention in Subjects With Early Stages of Age Related Macular Degeneration AMD for Safety and Exploratory Efficacy Outcomes
Status:
COMPLETED
Status Verified Date:
2023-05
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:
The purpose of this study is to assess the safety and tolerability of the RGEN Laser System in subjects with the early stages of age-related macular degeneration
Detailed Description:
This clinical study is a prospective single-center single-arm open-label pilot study to evaluate the safety and tolerability of the RGEN Laser System and to collect information on the severity of AMD in subjects with bilateral large drusen All participants will receive the intervention at the baseline visit and at the 24-week visit All participants will be evaluated at 24 and 48 weeks from the baseline visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None