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)

July 9, 2024 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Canada
        • Bayer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: anti-VEGF treatment
Follow clinical practice/administration
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
Drug: anti-VEGF treatment
Follow clinical practice/administration
nAMD patients, anti-VEGF experienced on treatment after July 2015
  • Cluster G: Likely to require frequent injections
  • Cluster H: Likely to extend treatment interval
Drug: anti-VEGF treatment
Follow clinical practice/administration
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
Drug: anti-VEGF treatment
Follow clinical practice/administration
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
Drug: anti-VEGF treatment
Follow clinical practice/administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Retrospective data analysis from January 1, 2009 to May 31, 2023.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Retrospective data analysis from January 1, 2009 to May 31, 2023.
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.
Retrospective data analysis from January 1, 2009 to May 31, 2023.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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