Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT06495203
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Understand the Usage of an Artificial Intelligence Technology Called DARWEN for Eye Disorders and to Find Out the Factors Influencing Treatment Frequencies in People With nAMD and RVO
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Establishing the Use of DARWEN AI Technology in Ophthalmology and Identifying Predictors of Treatment Intervals in nAMD and RVO
Status:
COMPLETED
Status Verified Date:
2024-07
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:
AIRSPEED
Brief Summary:
This is an observational study in which data already collected from people with the eye disorders below are studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Neovascular age-related macular edema (nAMD): an eye disorder caused by the lack of oxygen in the retina. The lack of oxygen leads to the increase of a protein called vascular endothelial growth factor (VEGF). VEGF causes new, weak blood vessels to grow. These vessels can leak fluid or blood into the central part of the retina at the back of the eye (macula). This leads to blurring or a blind spot in the central (straight ahead) vision needed for reading or threading a needle.
Retinal vein occlusion (RVO): an eye disorder where a blood vessel that carries blood away from the retina (vein) becomes blocked. The blocked vein causes a lack of oxygen in the retina which leads to the increase of VEGF and then vision disturbances.
These eye disorders can be treated with a type of medicine called anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGF treatment helps control the growth of new blood vessels in the eye and is given via injection into the eye.
DARWEN AI is a system using artificial intelligence (AI) technology. It has been proven that DARWEN AI can be used to extract data accurately and efficiently in multiple disease areas, including breast cancer, lung cancer, ambulatory care diseases and skin disorders.
The main purpose of this study is to validate if DARWEN AI can extract and sort through information from participants' health records accurately to identify those who need more frequent injections and those who do not.
The secondary purpose of this study is to use DARWEN AI to describe the factors influencing treatment frequencies in participants with nAMD or influencing treatment discontinuation in participants with RVO.
The data will come from the participants' information stored in EyeDoc Electronic Medical Records (EMR) at St. Joseph Health Care in London. Data collected are from January 1, 2009, to May 31, 2023.
Neovascular age-related macular edema (nAMD): an eye disorder caused by the lack of oxygen in the retina. The lack of oxygen leads to the increase of a protein called vascular endothelial growth factor (VEGF). VEGF causes new, weak blood vessels to grow. These vessels can leak fluid or blood into the central part of the retina at the back of the eye (macula). This leads to blurring or a blind spot in the central (straight ahead) vision needed for reading or threading a needle.
Retinal vein occlusion (RVO): an eye disorder where a blood vessel that carries blood away from the retina (vein) becomes blocked. The blocked vein causes a lack of oxygen in the retina which leads to the increase of VEGF and then vision disturbances.
These eye disorders can be treated with a type of medicine called anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGF treatment helps control the growth of new blood vessels in the eye and is given via injection into the eye.
DARWEN AI is a system using artificial intelligence (AI) technology. It has been proven that DARWEN AI can be used to extract data accurately and efficiently in multiple disease areas, including breast cancer, lung cancer, ambulatory care diseases and skin disorders.
The main purpose of this study is to validate if DARWEN AI can extract and sort through information from participants' health records accurately to identify those who need more frequent injections and those who do not.
The secondary purpose of this study is to use DARWEN AI to describe the factors influencing treatment frequencies in participants with nAMD or influencing treatment discontinuation in participants with RVO.
The data will come from the participants' information stored in EyeDoc Electronic Medical Records (EMR) at St. Joseph Health Care in London. Data collected are from January 1, 2009, to May 31, 2023.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: