Incidence of Macular Edema in a Uveitis Population

Macular edema from uveitis is a serious condition that can lead to vision loss. Uveitis is an inflammation inside the eye, and macular edema is when fluid builds up in the central part of the retina, called the macula, which is crucial for clear vision. This fluid buildup can blur vision, sometimes severely. Managing this condition can be challenging and may require several treatments to reduce the fluid and protect sight. While we know macular edema is a common cause of vision loss in uveitis, there's limited data on how often it affects people in Europe

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Non-Infectious Uveitis Retinal Degeneration Retinal Diseases Uveal Diseases Uveitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hospital-admitted patients in the North Denmark Region with non-infectious uveitis.
Both juvenile and adult patients.
Diagnosed with non-infectious uveitis by a medical doctor.
Patients presenting with unspecific macular edema may be included if medical records indicate uveitis as the cause of the edema.

Exclusion criteria

Patients incorrectly classified as having uveitis based on their medical records (no confirmed diagnosis of uveitis).
Patients with infectious uveitis.
Macular edema due to other cause than uveitis will not count as uveitis associated edema

Treatment and study plan

Local and systemical treatment

Drug

Evaluating the management of the edema including topical/local treatment (dexamethasone and NSAID, periocular injections, and dexamethasone intravitreal implant) and systemic treatment (prednisolone, DMARD, and biological agents, for example TNF-alpha inhibitors and interleukin-6 inhibitors). Moreover, the duration of any treatment as well as numbers of injections or implants.

Primary outcomes

Incidence of Macular Edema in patients with Uveitis

Time frame: 10 years

The outcome of interest is macular edema in non-infectious uveitis. We will estimate the incidence rate and cumulative incidence of macular edema in patients with uveitis. In addition, the population will be stratified according to sex, age, non-infectious uveitis subtype, HLA- subtype, and ethnicity (if available), and the rate and risk of macular edema will be assessed for each strata. The incidence rate for macular edema will be calculated for a 1-10 years follow-up periods. Furthermore, the cumulative incidence will be assessed using the Aalen Johansen estimator. The stratified groups will be compared using a cox proportional hazard model to quantify the differences between the respective groups. Patients will be excluded if essential information is missing in their medical journal. Follow-up will terminate in case the patient moves to an address outside the North Denmark Region.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Incidence of Macular Edema in a Uveitis Population of 1500 Patients

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Nov 13, 2024
Registry last updated: Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed