Retinal VasculitisNCT06769412
A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)
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 RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 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 2 mg
- How many people
- 550,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 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 to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR) without DME, DR with macular edema (ME) status unknown, or ME following retinal vein occlusion (RVO).
Who may be able to join
- Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023
- Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye
- Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)
Who cannot join
- Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol
- 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
- Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date
- NOTE: Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry
This study will describe and estimate the incidence of RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.
Read the detailed description
This study is purely descriptive using secondary data from the Verana Health Retinal Outcomes module sourced from the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry
- Conditions
- Retinal Vasculitis
- Being tested
- aflibercept 2 mg
- Keywords
- Anti-vascular endothelial growth factor, Aflibercept, Neovascular age-related macular degeneration (nAMD), Diabetic macular edema (DME), Diabetic retinopathy (DR) without macular edema (ME), Diabetic retinopathy (DR) with macular edema (ME)
- 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 2 mgDrug
Also called Eylea®
No study-specific investigations for this descriptive observational study
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept IVT Cohort | Patients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period Receives: Drug: aflibercept 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RV events
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of occlusive RV events confirmed through clinical chart abstraction
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of non-occlusive RV events confirmed through clinical chart abstraction
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of unconfirmed RV events
Measured: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jul 2025
- Primary completion15 Aug 2025
- Study completion1 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
- 550,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769412
- Sponsor's protocol ID
- VGFTe-OD-2457
- Status last verified
- Oct 2025
- First submitted
- 24 Dec 2024
- Last updated
- 29 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 29 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 2 mg: A US Real-World Evidence Study Using the IRIS Registry
- ClinicalTrials.gov ID
- NCT06769412
- Acronym / sponsor ID
- VGFTe-OD-2457
- Conditions
- Retinal Vasculitis
- Keywords
- Anti-vascular endothelial growth factor, Aflibercept, Neovascular age-related macular degeneration (nAMD), Diabetic macular edema (DME), Diabetic retinopathy (DR) without macular edema (ME), Diabetic retinopathy (DR) with macular edema (ME)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550,000 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 10 Jan 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 RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.
Detailed description
This study is purely descriptive using secondary data from the Verana Health Retinal Outcomes module sourced from the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept IVT Cohort | – | Drug: aflibercept 2 mgPatients ≥ 18 years who initiated aflibercept 2 mg 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 to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR) without DME, DR with macular edema (ME) status unknown, or ME following retinal vein occlusion (RVO).
Key inclusion criteria (3 listed)
- Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023
- Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye
- Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)
Key exclusion criteria (4 listed)
- Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol
- 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
- Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date
- NOTE: Other protocol defined inclusion/exclusion criteria may apply
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 2 mgAlso: Eylea®No study-specific investigations for this descriptive observational study | Drug | Aflibercept IVT Cohort |
Primary outcome
Incidence of RV events
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of occlusive RV events confirmed through clinical chart abstraction
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of non-occlusive RV events confirmed through clinical chart abstraction
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of unconfirmed RV events
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 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 29 Oct 2025.
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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 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 3 inclusion and 4 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 29 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 6.5 years). The study lists 4 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 29 Oct 2025.