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BRVO patients, anti-VEGF naïve on treatment after March 2017 for Age-Related Macular Degeneration (AIRSPEED Trial)

N/A
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up retrospective data analysis from january 1, 2009 to may 31, 2023.
Awards & highlights

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.

Eligible Conditions
  • Age-Related Macular Degeneration
  • Retinal Vein Occlusion

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~retrospective data analysis from january 1, 2009 to may 31, 2023.
This trial's timeline: 3 weeks for screening, Varies for treatment, and retrospective data analysis from january 1, 2009 to may 31, 2023. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Validation of DARWEN™ AI.
Secondary study objectives
Summary of baseline demographics reported as number of participants with different categories.
Summary of clinical characteristics reported as number of participants with different categories.

Trial Design

5Treatment groups
Experimental Treatment
Group I: nAMD patients, anti-VEGF naïve on treatment before July 2015Experimental Treatment1 Intervention
* Cluster D: Likely to require frequent injections * Cluster E: Probable to extend treatment interval * Cluster F: Likely to extend treatment interval
Group II: nAMD patients, anti-VEGF naïve on treatment after July 2015Experimental Treatment1 Intervention
* Cluster A: Likely to require frequent injections * Cluster B: Probable to extend treatment interval * Cluster C: Likely to extend treatment interval
Group III: nAMD patients, anti-VEGF experienced on treatment after July 2015Experimental Treatment1 Intervention
* Cluster G: Likely to require frequent injections * Cluster H: Likely to extend treatment interval
Group IV: CRVO patients, anti-VEGF naïve on treatment after July 2015Experimental Treatment1 Intervention
* Cluster A: Likely to require continued anti-VEGF treatment * Cluster B: Likely to be off anti-VEGF treatment
Group V: BRVO patients, anti-VEGF naïve on treatment after March 2017Experimental Treatment1 Intervention
* Cluster C: Likely to require continued anti-VEGF treatment * Cluster D: Likely to be off anti-VEGF treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
anti-VEGF treatment
2021
N/A
~1400

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Who is running the clinical trial?

BayerLead Sponsor
2,260 Previous Clinical Trials
25,308,095 Total Patients Enrolled
~736 spots leftby Sep 2025
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