Intraocular InflammationNCT05791695
A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
An observational study of Intraocular Inflammation and Suspected Endophthalmitis, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
Specific study objectives include: To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Inflammation, Suspected Endophthalmitis
- What is being tested?
- Non Applicable
- Type of treatment
- Injection or infusion
- How many people
- 155,413 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2022to 15 Sep 2023
- 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 period will span from 01 Jan 2014 (earliest complete data available) to 28 May 2022 (or most current data available). The study will include patients ≥18 years of age in Vestrum who have received one or more injections of aflibercept, regardless of indication, between 01 Jan 2014 to 30 Apr 2022 (one month look forward required). Patients must have at least one eligible treatment episode (defined as aflibercept injection followed by 28-day exposed period after injection) to be included in the study.
Who may be able to join
- Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022
- Patients must have at least one eligible treatment episode a. Specification of laterality of aflibercept injection (left or right eye or both) for treatment episode
Who cannot join
- A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol
- Active steroid treatment, defined as steroid treatment (topical or intravitreal) on the date of aflibercept injection. This criterion is limited to date of aflibercept injection since steroids may be used to treat IOIs.
- Any treatment episode where a patient eye receives >1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A US Real-World Evidence Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
Specific study objectives include:
- To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).
- To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.
Secondary objectives
- To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.
Read the detailed description
This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.
- Being tested
- Non Applicable
- Keywords
- Age-related macular degeneration, Anti-vascular endothelial growth factor, Diabetic macular edema, Diabetic retinopathy, Endophthalmitis, Intraocular inflammation, Retinal vein occlusion, Vascular endothelial growth factor
- Medical subject headings
- Uveitis, Macular Degeneration, Diabetic Retinopathy, Endophthalmitis, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non ApplicableOther
No study-specific interventions for this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Study Patients | Patients ≥ 18 years who have received one or more injections of aflibercept during the study period Receives: Other: Non Applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients receiving aflibercept injections
Measured: End of Study, Approximately 8 Years
Frequency of aflibercept injections by ophthalmic delivery mechanism
Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Measured: End of Study, Approximately 8 Years
Incidence of Intraocular inflammation (IOI)
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-9 and ICD-10) diagnosis codes.
Measured: End of Study, Approximately 8 Years
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism
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-9 and ICD-10) diagnosis codes.
Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Measured: End of Study, Approximately 8 Years
Incidence of suspected endophthalmitis
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-9 and ICD-10) diagnosis codes.
Measured: End of Study, Approximately 8 Years
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism
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-9 and ICD-10) diagnosis codes.
Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Measured: End of Study, Approximately 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start16 Sep 2022
- Primary completion30 Dec 2022
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular InflammationStudies 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
- 155,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791695
- Sponsor's protocol ID
- VGFTe-OD-2222
- Status last verified
- Oct 2023
- First submitted
- 27 Feb 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A US Real-World Evidence Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
- ClinicalTrials.gov ID
- NCT05791695
- Acronym / sponsor ID
- VGFTe-OD-2222
- Keywords
- Age-related macular degeneration, Anti-vascular endothelial growth factor, Diabetic macular edema, Diabetic retinopathy, Endophthalmitis, Intraocular inflammation, Retinal vein occlusion, Vascular endothelial growth factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155,413 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 30 Mar 2023 (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.
Specific study objectives include:
- To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).
- To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.
Secondary objectives
- To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.
Detailed description
This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Patients | – | Other: Non ApplicablePatients ≥ 18 years who have received one or more injections of aflibercept 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 period will span from 01 Jan 2014 (earliest complete data available) to 28 May 2022 (or most current data available). The study will include patients ≥18 years of age in Vestrum who have received one or more injections of aflibercept, regardless of indication, between 01 Jan 2014 to 30 Apr 2022 (one month look forward required). Patients must have at least one eligible treatment episode (defined as aflibercept injection followed by 28-day exposed period after injection) to be included in the study.
Key inclusion criteria (2 listed)
- Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022
- Patients must have at least one eligible treatment episode a. Specification of laterality of aflibercept injection (left or right eye or both) for treatment episode
Key exclusion criteria (3 listed)
- A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol
- Active steroid treatment, defined as steroid treatment (topical or intravitreal) on the date of aflibercept injection. This criterion is limited to date of aflibercept injection since steroids may be used to treat IOIs.
- Any treatment episode where a patient eye receives >1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).
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 |
|---|---|---|
| Non ApplicableNo study-specific interventions for this observational study. | Other | Study Patients |
Primary outcome
Frequency of patients receiving aflibercept injections
Time frame: End of Study, Approximately 8 Years
Frequency of aflibercept injections by ophthalmic delivery mechanism
Time frame: End of Study, Approximately 8 Years
Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Incidence of Intraocular inflammation (IOI)
Time frame: End of Study, Approximately 8 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-9 and ICD-10) diagnosis codes.
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism
Time frame: End of Study, Approximately 8 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-9 and ICD-10) diagnosis codes. Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Incidence of suspected endophthalmitis
Time frame: End of Study, Approximately 8 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-9 and ICD-10) diagnosis codes.
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism
Time frame: End of Study, Approximately 8 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-9 and ICD-10) diagnosis codes. Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
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 Intraocular Inflammation and Suspected Endophthalmitis, 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 2 inclusion and 3 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 1 Dec 2023. 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?
Frequency of patients receiving aflibercept injections (time frame: End of Study, Approximately 8 Years). The study lists 6 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 1 Dec 2023.