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 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bayer

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

I am a patient of Dr. Tom Sheidow with nAMD or RVO, and my records are in the EyeDoc EHR from Jan 1, 2009 to May 31, 2023.

Treatment Details

Participant Groups

5Treatment groups

Experimental Treatment

Group I: nAMD patients, anti-VEGF naïve on treatment before July 2015Experimental Treatment1 Intervention

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

Group II: nAMD patients, anti-VEGF naïve on treatment after July 2015Experimental Treatment1 Intervention

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

Group III: nAMD patients, anti-VEGF experienced on treatment after July 2015Experimental Treatment1 Intervention

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

Group IV: CRVO patients, anti-VEGF naïve on treatment after July 2015Experimental Treatment1 Intervention

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

Group V: BRVO patients, anti-VEGF naïve on treatment after March 2017Experimental Treatment1 Intervention

* Cluster C: Likely to require continued anti-VEGF treatment * Cluster D: Likely to be off anti-VEGF treatment