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OpenTrials
Completed

NCT Number: NCT06495203

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Mississauga, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-VEGF treatment

Drug

Follow clinical practice/administration

Primary outcomes

  1. Validation of DARWEN™ AI.

    Time frame: Retrospective data analysis from January 1, 2009 to May 31, 2023.

    Based on defined objective clinical eligibility criteria, the EMR data set was divided into four cohorts using Pentavere's proprietary AI engine DARWEN™. The following ophthalmology-specific variables were validated against a manual review: diagnosis of nAMD, diagnosis of RVO including CRVO and BRVO, treatment intervals of anti-VEGF treatment grouped as < Q8 weeks or ≥ Q8 weeks for nAMD patients, discontinuation of anti-VEGF treatment for RVO patients, and the final outputted cohorts. The manual review was performed on a random selection of 25 patients from each of the four cohorts (100 patients total). Two trained manual abstractors classified these patients according to the rules outlined in the objective cohort criteria. They aligned on a consensus for each patient and compared with the DARWEN™cohorts. Pentavere then provided a success rate for the accuracy of the classification.

Secondary outcomes

  1. Summary of baseline demographics reported as number of participants with different categories.

    Time frame: Retrospective data analysis from January 1, 2009 to May 31, 2023.

    Age, sex.

  2. Summary of clinical characteristics reported as number of participants with different categories.

    Time frame: Retrospective data analysis from January 1, 2009 to May 31, 2023.

    Baseline ophthalmology characteristics, ocular comorbidities, other comorbidities, family history, etc.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Establishing the Use of DARWEN AI Technology in Ophthalmology and Identifying Predictors of Treatment Intervals in nAMD and RVO

Acronym: AIRSPEED

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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