Neovascular Age-related Macular DegenerationAIRSPEEDNCT06495203
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
An observational study of Neovascular Age-related Macular Degeneration and Retinal Vein Occlusion, run by Bayer at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion
- What is being tested?
- anti-VEGF treatment
- Type of treatment
- Injection or infusion
- How many people
- 1,350 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2023to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- anti-VEGF treatment
- Keywords
- nAMD, RVO, Central retinal vein occlusion, CRVO, Branch retinal vein occlusion, BRVO
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-VEGF treatmentDrug
Follow clinical practice/administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: anti-VEGF treatment | |
| 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 Receives: Drug: anti-VEGF treatment | |
| nAMD patients, anti-VEGF experienced on treatment after July 2015 | * Cluster G: Likely to require frequent injections
* Cluster H: Likely to extend treatment interval Receives: Drug: anti-VEGF treatment | |
| 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 Receives: Drug: 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 Receives: Drug: anti-VEGF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Age, sex.
Measured: 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.
Measured: Retrospective data analysis from January 1, 2009 to May 31, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start2 Nov 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495203
- Sponsor's protocol ID
- 22642
- Acronym
- AIRSPEED
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Use of DARWEN AI Technology in Ophthalmology and Identifying Predictors of Treatment Intervals in nAMD and RVO
- ClinicalTrials.gov ID
- NCT06495203
- Acronym / sponsor ID
- AIRSPEED / 22642
- Keywords
- nAMD, RVO, Central retinal vein occlusion, CRVO, Branch retinal vein occlusion, BRVO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| nAMD patients, anti-VEGF naïve on treatment after July 2015 | – | Drug: anti-VEGF treatment* 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 | – | Drug: anti-VEGF treatment* 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 | – | Drug: anti-VEGF treatment* Cluster G: Likely to require frequent injections * Cluster H: Likely to extend treatment interval |
| CRVO patients, anti-VEGF naïve on treatment after July 2015 | – | Drug: anti-VEGF treatment* 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 | – | Drug: anti-VEGF treatment* Cluster C: Likely to require continued anti-VEGF treatment * Cluster D: Likely to be off anti-VEGF treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-VEGF treatmentFollow clinical practice/administration | Drug | BRVO patients, anti-VEGF naïve on treatment after March 2017, CRVO patients, anti-VEGF naïve on treatment after July 2015, nAMD patients, anti-VEGF experienced on treatment after July 2015, nAMD patients, anti-VEGF naïve on treatment after July 2015, nAMD patients, anti-VEGF naïve on treatment before July 2015 |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. 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.
Related trials for Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 3
A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)
Neovascular Age-related Macular Degeneration (nAMD)
RecruitingPhase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
Active, not recruitingPhase 4
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age-related Macular Degeneration (nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration and Retinal Vein Occlusion, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of DARWEN™ AI. (time frame: Retrospective data analysis from January 1, 2009 to May 31, 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.