check_circleStudy Completed

Neovascular age-related macular degeneration, Retinal vein occlusion

Bayer Identifier:

22642

ClinicalTrials.gov Identifier:

NCT06495203

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - Not applicable.

Trial summary

Enrollment Goal
1350
Trial Dates
November 2023 - February 2024
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BayerMississauga, Canada
Completed
BayerMississauga, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Retrospective data analysis from January 1, 2009 to May 31, 2023.

Secondary Outcome

  • Summary of baseline demographics reported as number of participants with different categories.
    Age, sex.
    date_rangeTime Frame:
    Retrospective data analysis from January 1, 2009 to May 31, 2023.
  • Summary of clinical characteristics reported as number of participants with different categories.
    Baseline ophthalmology characteristics, ocular comorbidities, other comorbidities, family history, etc.
    date_rangeTime Frame:
    Retrospective data analysis from January 1, 2009 to May 31, 2023.

Trial design

Establishing the Use of DARWEN AI Technology in Ophthalmology and identifying predictors of treatment intervals in nAMD and RVO
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here for access to information about Bayer’s transparency standards and Bayer studies.