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
Establishing the Use of DARWEN AI Technology in Ophthalmology and Identifying Predictors of Treatment Intervals in nAMD and RVO
1 other identifier
observational
1,350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedFirst Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedJuly 10, 2024
July 1, 2024
4 months
July 3, 2024
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation of DARWEN™ AI.
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.
Retrospective data analysis from January 1, 2009 to May 31, 2023.
Secondary Outcomes (2)
Summary of baseline demographics reported as number of participants with different categories.
Retrospective data analysis from January 1, 2009 to May 31, 2023.
Summary of clinical characteristics reported as number of participants with different categories.
Retrospective data analysis from January 1, 2009 to May 31, 2023.
Study Arms (5)
nAMD patients, anti-VEGF naïve on treatment after July 2015
* Cluster A: Likely to require frequent injections * Cluster B: Probable to extend treatment interval * Cluster C: Likely to extend treatment interval
nAMD patients, anti-VEGF naïve on treatment before July 2015
* Cluster D: Likely to require frequent injections * Cluster E: Probable to extend treatment interval * Cluster F: Likely to extend treatment interval
nAMD patients, anti-VEGF experienced on treatment after July 2015
* Cluster G: Likely to require frequent injections * Cluster H: Likely to extend treatment interval
CRVO patients, anti-VEGF naïve on treatment after July 2015
* Cluster A: Likely to require continued anti-VEGF treatment * Cluster B: Likely to be off anti-VEGF treatment
BRVO patients, anti-VEGF naïve on treatment after March 2017
* Cluster C: Likely to require continued anti-VEGF treatment * Cluster D: Likely to be off anti-VEGF treatment
Interventions
Follow clinical practice/administration
Eligibility Criteria
All patients with the diagnosis of nAMD or RVO (Branch or Central) who are patients of Dr. Tom Sheidow listed in the EyeDoc Electronic Health Record (EHR) with available patient records from Jan 1, 2009 to May 31, 2023.
You may qualify if:
- 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.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Bayer
Mississauga, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 10, 2024
Study Start
November 2, 2023
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.