Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-02
Brief Title:
Personalized Monitoring of Non-foveal Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Personalized Monitoring of Non-foveal Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective Multinational Multicenter Observational Study
Status:
NOT_YET_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:
APENNINES
Brief Summary:
The goal of this prospective multinational multicenter observational study is to assess and predict progression in non-foveal non-vision compromising atrophic AMD on an individual-based level over two years The main objectives of this study are
Assess the individual progression rate of a patient in non-foveal non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging
Identify and quantify focal and global alterations in the retina in regard to disease progression
Evaluate the monitoring of AMD progression using approved AI algorithms
All patients will be followed for 24 months with 6 month intervals to assess clinical changes Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures
Scanning Laser Fundus Photography
Color Fundus Photography CFP
Optical Coherence Tomography OCT
Optical Coherence Tomography Angiography OCTA
Patients will be asked for their medical history Standard ophthalmic examination as well as a questionnaire on visual function will be carried out
No intervention will be performed during the study since no treatment is yet available within Europe As soon as treatment is approved in the EU patients in this cohort might receive treatment according to availability in their respective country and standard of care If treatment will be performed it will be as standard of care outside the study according to each countrys standard of care and by EMA label
Assess the individual progression rate of a patient in non-foveal non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging
Identify and quantify focal and global alterations in the retina in regard to disease progression
Evaluate the monitoring of AMD progression using approved AI algorithms
All patients will be followed for 24 months with 6 month intervals to assess clinical changes Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures
Scanning Laser Fundus Photography
Color Fundus Photography CFP
Optical Coherence Tomography OCT
Optical Coherence Tomography Angiography OCTA
Patients will be asked for their medical history Standard ophthalmic examination as well as a questionnaire on visual function will be carried out
No intervention will be performed during the study since no treatment is yet available within Europe As soon as treatment is approved in the EU patients in this cohort might receive treatment according to availability in their respective country and standard of care If treatment will be performed it will be as standard of care outside the study according to each countrys standard of care and by EMA label
Detailed Description:
None
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