Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351605
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration EUROLIGHT EUROLIGHT
Sponsor:
LumiThera Inc
Organization:
LumiThera Inc
Study Overview
Official Title:
A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation in Participants With Dry Age-Related Macular Degeneration EUROLIGHT
Status:
RECRUITING
Status Verified Date:
2024-04
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 EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD in routine clinical practice both retrospectively and prospectively
Detailed Description:
This is a multi-center retrospective and prospective registry study on the use of the Valeda PBM system as a treatment for visual improvement in participants with dry AMD The target is at least 25 participantssite in up to 20 participating sites in Europe
Participants will or will have received nine non-invasive short treatments over three to four weeks starting at Baseline BL with up to five additional rounds of treatment every four to six months or as determined by the Investigator
Standard visual outcome measurements collected will include visual acuity either ETDRS BCVA or LogMAR prior to and following treatment OCT and Fundus Autofluorescence FAF imaging of the retina should be taken at screening and after each round of treatment As this is a registry study missing
Participants will or will have received nine non-invasive short treatments over three to four weeks starting at Baseline BL with up to five additional rounds of treatment every four to six months or as determined by the Investigator
Standard visual outcome measurements collected will include visual acuity either ETDRS BCVA or LogMAR prior to and following treatment OCT and Fundus Autofluorescence FAF imaging of the retina should be taken at screening and after each round of treatment As this is a registry study missing
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?:
None
Is an FDA AA801 Violation?:
None