Real-World Incidence of Intraocular Inflammation Following Intravitreal Treatment With Aflibercept 8 mg

NCT07849309 | Completed FDA Drug

• 1 other identifier: p-2026-21310
• Study Type: observational
• Target: 3,690
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

adverse event; aflibercept 8 mg; anti-VEGF; intraocular inflammation; intravitreal injection; real-world data

Outcome Measures

Primary Outcomes (1)

• Incidence of IOI following an intravitreal aflibercept 8 mg injection

  Reported per patient, per eye and per injection

  01/DEC/2024 - 30/NOV/2025

Secondary Outcomes (5)

• Anatomical IOI phenotype

  01/DEC/2024 - 30/NOV/2025

• Time from injection to IOI symptom onset

  01/DEC/2024 - 30/NOV/2025

• Disease duration of IOI

  01/DEC/2024 - 30/NOV/2025

• Treatment strategy after the IOI event

  01/DEC/2024 - 30/NOV/2025

• Functional outcome after the IOI event

  01/DEC/2024 - 30/NOV/2025

Other Outcomes (1)

• Comparisons by demographic characteristics, diagnosis and treatment status

  01/DEC/2024 - 30/NOV/2025

Study Arms (1)

Received aflibercept 8mg intravitreal injections

Drug: Aflibercept (Eylea)

Interventions

Aflibercept (Eylea) DRUG

intravitreal injection

Also known as: aflibercept 8mg

Received aflibercept 8mg intravitreal injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \>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

You may not qualify if:

• Patients with incomplete medical records

Sponsors & Collaborators

• Copenhagen University Hospital, Rigshospitalet: lead

Study Sites (1)

Rigshospitalet, Department of Ophthalmology

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Uveitis

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Clinical Associate Professor

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: April 20, 2026
• Primary Completion: August 10, 2026
• Study Completion: September 14, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)