Incidence of Macular Edema in a Uveitis Population

NCT ID: NCT06686641

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-02-01

Brief Summary

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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

Detailed Description

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Conditions

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Macular Edema Non-infectious Uveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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

Local and systemical treatment

Intervention Type 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.

Interventions

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Local and systemical treatment

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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lasse Jørgensen Cehofski

Dr. Lasse J. Cehofski

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lasse J Cehofski, MD, P.h.d

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 37440091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30858697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31571815 (View on PubMed)

Other Identifiers

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ML45555

Identifier Type: -

Identifier Source: org_study_id

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