Retinal VasculitisNCT07105228
Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study
An observational study of Retinal Vasculitis, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vasculitis
- What is being tested?
- aflibercept 2mg
- How many people
- 290,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 15 Sep 2025
- 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: The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections
Who may be able to join
- 1. All aflibercept injections identified by the Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) from January 1, 2017, to February 29, 2024, as recorded in the Komodo close claims database.
Who cannot join
- Aflibercept injections with unspecified laterality will be excluded
- Aflibercept injections from individuals aged <18 years or those with unknown age on the injection date will be excluded
- Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol
- Patient-eyes that do not meet the continuous enrollment requirement will be excluded
- Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
1 site in 1 country.
About this study
This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice.
The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.
Read the detailed description
This study is purely descriptive using US claims data from Komodo Healthcare Map.
- Conditions
- Retinal Vasculitis
- Being tested
- aflibercept 2mg
- Keywords
- Anti-Vascular Endothelial Growth Factor (VEGF), Aflibercept, neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema Following Retinal Vein Occlusion (RVO)
- Medical subject headings
- Retinal Vasculitis, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflibercept 2mgDrug
Also called Eylea®
No study-specific interventions administered in this observational study
| Study group | Role | What they receive |
|---|---|---|
| Study Patients | Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period Receives: Drug: aflibercept 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RV events
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence of RV plus IOI events
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Demographics characteristics
Demographics include: sex, age, race/ethnicity, insurance, geographic area
Measured: 12 months prior to the index date
Clinical characteristics: Number of participants with different retinal disease diagnosis categories
Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion [MEfRVO])
Measured: 12 months prior to the index date
Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score
The Charlson Comorbidity Index (CCI) is a method used to categorize comorbidities based on International Classification of Diseases (ICD) diagnosis codes. A score of 0 indicates that no comorbidities were found, while higher scores correspond to increased predicted mortality
Measured: 12 months prior to the index date
Clinical characteristics: Summary of comorbidities reported as number of participants with different categories
Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia
Measured: 12 months prior to the index date
Clinical characteristics: Number of participants with prior anti-VEGF treatment
Measured: 12 months prior to the index date
Secondary outcomes (1)
Incidence of RV plus RO
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Jul 2025
- Primary completion30 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal VasculitisStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- 290,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105228
- Sponsor's protocol ID
- VGFTe-OD-2458
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study
- ClinicalTrials.gov ID
- NCT07105228
- Acronym / sponsor ID
- VGFTe-OD-2458
- Conditions
- Retinal Vasculitis
- Keywords
- Anti-Vascular Endothelial Growth Factor (VEGF), Aflibercept, neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema Following Retinal Vein Occlusion (RVO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290,000 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 5 Aug 2025 (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 study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice.
The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.
Detailed description
This study is purely descriptive using US claims data from Komodo Healthcare Map.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Patients | – | Drug: aflibercept 2mgPatients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections
Key inclusion criteria (1 listed)
- 1. All aflibercept injections identified by the Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) from January 1, 2017, to February 29, 2024, as recorded in the Komodo close claims database.
Key exclusion criteria (6 listed)
- Aflibercept injections with unspecified laterality will be excluded
- Aflibercept injections from individuals aged <18 years or those with unknown age on the injection date will be excluded
- Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol
- Patient-eyes that do not meet the continuous enrollment requirement will be excluded
- Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date
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 |
|---|---|---|
| aflibercept 2mgAlso: Eylea®No study-specific interventions administered in this observational study | Drug | Study Patients |
Primary outcome
Incidence of RV events
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Incidence of RV plus IOI events
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Demographics characteristics
Time frame: 12 months prior to the index date
Demographics include: sex, age, race/ethnicity, insurance, geographic area
Clinical characteristics: Number of participants with different retinal disease diagnosis categories
Time frame: 12 months prior to the index date
Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion [MEfRVO])
Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score
Time frame: 12 months prior to the index date
The Charlson Comorbidity Index (CCI) is a method used to categorize comorbidities based on International Classification of Diseases (ICD) diagnosis codes. A score of 0 indicates that no comorbidities were found, while higher scores correspond to increased predicted mortality
Clinical characteristics: Summary of comorbidities reported as number of participants with different categories
Time frame: 12 months prior to the index date
Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia
Clinical characteristics: Number of participants with prior anti-VEGF treatment
Time frame: 12 months prior to the index date
1 secondary outcome
Incidence of RV plus RO
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
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 Oct 2025.
Related trials for Retinal Vasculitis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Giant Cell Arteritis (GCA), Ischemic Optic Neuropathy
RecruitingObservational study
Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
Anterior Uveitis (AU), Birdshot Chorioretinitis
RecruitingObservational study
Visual Involvement in Giant Cell Arteritis
Giant Cell Arteritis, Visual Impairment
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 Retinal Vasculitis, run by Regeneron Pharmaceuticals at 1 site in United States.
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 6 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 Oct 2025. 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 United States. 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?
Incidence of RV events (time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years). The study lists 7 primary outcomes in all. 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 Oct 2025.