Intraocular InflammationNCT07849309
Real-World Incidence of Intraocular Inflammation Following Intravitreal Treatment With Aflibercept 8 mg
An observational study of Intraocular Inflammation and Intravitreal Injections, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Aflibercept 8 mg is a high-concentration anti-vascular endothelial growth factor therapy developed to extend treatment intervals for retinal diseases while maintaining the efficacy and safety of aflibercept 2 mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Inflammation, Intravitreal Injections
- What is being tested?
- Aflibercept (Eylea)
- Type of treatment
- Injection or infusion
- How many people
- 3,690 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2026to 14 Sep 2026
- 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: Consecutive patients who received at least 1 intravitreal aflibercept 8mg injection between 01/DEC/2024 and 30/NOV/2025 at the Department of Ophthalmology, Rigshospitalet, Denmark
Who may be able to join
- >18 years of age
- Have received at least 1 intravitreal aflibercept 8mg injection at our center
- Follow-up period of at least 6 weeks after the injection
Who cannot join
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Department of Ophthalmology
Glostrup Municipality, 2600
About this study
Aflibercept 8 mg is a high-concentration anti-vascular endothelial growth factor therapy developed to extend treatment intervals for retinal diseases while maintaining the efficacy and safety of aflibercept 2 mg. Phase 3 trials supported its use in neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
The aim of this study was to estimate the incidence of intraocular inflammation (IOI) after intravitreal aflibercept 8 mg injections in an unselected cohort treated at a large tertiary referral center, and describe the presentation, management and outcome of the affected eyes.
- Conditions
- Intraocular Inflammation, Intravitreal Injections
- Being tested
- Aflibercept (Eylea)
- Keywords
- adverse event, aflibercept 8 mg, anti-VEGF, intraocular inflammation, intravitreal injection, real-world data
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea)Drug
Also called aflibercept 8mg
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Received aflibercept 8mg intravitreal injections | Not described Receives: Drug: Aflibercept (Eylea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IOI following an intravitreal aflibercept 8 mg injection
Reported per patient, per eye and per injection
Measured: 01/DEC/2024 - 30/NOV/2025
Secondary outcomes (5)
Anatomical IOI phenotype
Described after the SUN classification system
Measured: 01/DEC/2024 - 30/NOV/2025
Time from injection to IOI symptom onset
Described in days
Measured: 01/DEC/2024 - 30/NOV/2025
Disease duration of IOI
Described in days
Measured: 01/DEC/2024 - 30/NOV/2025
Treatment strategy after the IOI event
Description of the type of drug or intervention used
Measured: 01/DEC/2024 - 30/NOV/2025
Functional outcome after the IOI event
Described in logMAR best-corrected visual acuity
Measured: 01/DEC/2024 - 30/NOV/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start20 Apr 2026
- Primary completion10 Aug 2026
- Study completion14 Sep 2026
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 Copenhagen University Hospital, RigshospitaletThe 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
- 3,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Schneider MD, PhD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849309
- Sponsor's protocol ID
- p-2026-21310
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Raw data sharing with third parties was not approved for this project.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Incidence of Intraocular Inflammation Following Intravitreal Treatment With Aflibercept 8 mg
- ClinicalTrials.gov ID
- NCT07849309
- Acronym / sponsor ID
- p-2026-21310
- Conditions
- Intraocular Inflammation, Intravitreal Injections
- Keywords
- adverse event, aflibercept 8 mg, anti-VEGF, intraocular inflammation, intravitreal injection, real-world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,690 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 30 Sep 2026 (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.
Aflibercept 8 mg is a high-concentration anti-vascular endothelial growth factor therapy developed to extend treatment intervals for retinal diseases while maintaining the efficacy and safety of aflibercept 2 mg. Phase 3 trials supported its use in neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
The aim of this study was to estimate the incidence of intraocular inflammation (IOI) after intravitreal aflibercept 8 mg injections in an unselected cohort treated at a large tertiary referral center, and describe the presentation, management and outcome of the affected eyes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received aflibercept 8mg intravitreal injections | – | Drug: Aflibercept (Eylea) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who received at least 1 intravitreal aflibercept 8mg injection between 01/DEC/2024 and 30/NOV/2025 at the Department of Ophthalmology, Rigshospitalet, Denmark
Key inclusion criteria (3 listed)
- >18 years of age
- Have received at least 1 intravitreal aflibercept 8mg injection at our center
- Follow-up period of at least 6 weeks after the injection
Key exclusion criteria (1 listed)
- Patients with incomplete medical records
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 (Eylea)Also: aflibercept 8mgintravitreal injection | Drug | Received aflibercept 8mg intravitreal injections |
Primary outcome
Incidence of IOI following an intravitreal aflibercept 8 mg injection
Time frame: 01/DEC/2024 - 30/NOV/2025
Reported per patient, per eye and per injection
5 secondary outcomes
Anatomical IOI phenotype
Time frame: 01/DEC/2024 - 30/NOV/2025
Time from injection to IOI symptom onset
Time frame: 01/DEC/2024 - 30/NOV/2025
Disease duration of IOI
Time frame: 01/DEC/2024 - 30/NOV/2025
Treatment strategy after the IOI event
Time frame: 01/DEC/2024 - 30/NOV/2025
Functional outcome after the IOI event
Time frame: 01/DEC/2024 - 30/NOV/2025
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Raw data sharing with third parties was not approved for this project.
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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 Intraocular Inflammation and Intravitreal Injections, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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 30 Sep 2026. 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 Denmark. 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 IOI following an intravitreal aflibercept 8 mg injection (time frame: 01/DEC/2024 - 30/NOV/2025). 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 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.