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 (AIRSPEED)

Bayer

Status

Completed

Conditions

Neovascular Age-related Macular Degeneration

Retinal Vein Occlusion

Treatments

Drug: anti-VEGF treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT06495203

22642

Details and patient eligibility

About

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.

Enrollment

1,350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients with the diagnosis of nAMD or RVO (Branch or Central) who are patients of Dr. Tom Sheidow listed in the EyeDoc EHR with available patient records from Jan 1, 2009 to May 31, 2023.

Exclusion criteria

Not applicable.

Trial design

1,350 participants in 5 patient groups

nAMD patients, anti-VEGF naïve on treatment after July 2015

Description:

* Cluster A: Likely to require frequent injections * Cluster B: Probable to extend treatment interval * Cluster C: Likely to extend treatment interval

Treatment:

Drug: anti-VEGF treatment

nAMD patients, anti-VEGF naïve on treatment before July 2015

Description:

* Cluster D: Likely to require frequent injections * Cluster E: Probable to extend treatment interval * Cluster F: Likely to extend treatment interval

Treatment:

Drug: anti-VEGF treatment

nAMD patients, anti-VEGF experienced on treatment after July 2015

Description:

* Cluster G: Likely to require frequent injections * Cluster H: Likely to extend treatment interval

Treatment:

Drug: anti-VEGF treatment

CRVO patients, anti-VEGF naïve on treatment after July 2015

Description:

* Cluster A: Likely to require continued anti-VEGF treatment * Cluster B: Likely to be off anti-VEGF treatment

Treatment:

Drug: anti-VEGF treatment