Incidence of Macular Edema in a Uveitis Population

NCT06686641 | Active Not Recruiting

• 1 other identifier: ML45555
• Study Type: observational
• Target: 1,550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Macular Edema; Non-infectious Uveitis

Keywords

Epidemiology of uveitis; Incidence of macular edema in a uveitis population; Management of macular edema secondary to uveitis; Uveitis; Macular Edema; Non infectious uveitis; Non-infectious uveitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Macular Edema in patients with Uveitis

  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.

  10 years

Study Arms (1)

Non-infectious uveitis patients treated at a hospitals in the North Denmark Region

Drug: Local and systemical treatment

Interventions

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.

Non-infectious uveitis patients treated at a hospitals in the North Denmark Region

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all uveitis patients treated at hospitals in the North Denmark Region.The included study population consists of all patients with a primary or secondary first-time discharge diagnosis of uveitis from the ophthalmologic department at Aalborg University Hospital in the North Denmark Region. Both inpatient and outpatient diagnoses are included. The following ICD-10 codes for uveitis will be included: DH200 acute and subacute anterior uveitis, DH201 Chronic anterior uveitis, DH209 anterior uveitis unspecified, DH208 other anterior uveitis, DH300 focal posterior uveitis, DH309 posterior uveitis unspecified, DH308 other posterior uveitis, DH301 disseminated posterior uveitis, DH302 intermediate uveitis, and DH441E panuveitis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (4)

• Ørskov et al. J Pers Med. 2023 8;13(6):970

  BACKGROUND

• Xue YQ, Xiao JA, Chen Y. Frequency and Treatment Regimens of Macular Edema in 1946 Consecutive Patients with Noninfectious Uveitis at a Tertiary Ophthalmic Center in Shaanxi, China. Ophthalmol Ther. 2023 Oct;12(5):2609-2619. doi: 10.1007/s40123-023-00763-4. Epub 2023 Jul 13.

  PMID: 37440091 BACKGROUND

• Koronis S, Stavrakas P, Balidis M, Kozeis N, Tranos PG. Update in treatment of uveitic macular edema. Drug Des Devel Ther. 2019 Feb 19;13:667-680. doi: 10.2147/DDDT.S166092. eCollection 2019.

  PMID: 30858697 BACKGROUND

• Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clin Ophthalmol. 2019 Sep 10;13:1761-1777. doi: 10.2147/OPTH.S180580. eCollection 2019.

  PMID: 31571815 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Uveitis

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Uveal Diseases

Study Officials

• Lasse J Cehofski, MD, P.h.d

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lasse J. Cehofski

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: February 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)