Macular EdemaNCT06686641
Incidence of Macular Edema in a Uveitis Population
An observational study of Macular Edema and Non-infectious Uveitis, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema, Non-infectious Uveitis
- What is being tested?
- Local and systemical treatment
- Type of treatment
- Injection or infusion
- How many people
- 1,550 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2024to 1 Feb 2025
- How long will I take part?
- 15 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Macular Edema in a Uveitis Population of 1500 Patients
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
- Being tested
- Local and systemical treatment
- 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
- Medical subject headings
- Macular Edema, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local and systemical treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-infectious uveitis patients treated at a hospitals in the North Denmark Region | Not described Receives: Drug: Local and systemical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 May 2024
- Primary completion31 Oct 2024
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Other
- Enrolment
- 1,550 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Jørgensen Cehofski, Aalborg University Hospital
- Investigators
- Lasse J Cehofski, MD, P.h.d, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686641
- Sponsor's protocol ID
- ML45555
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ørskov et al. J Pers Med. 2023 8;13(6):970
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.
PubMed 37440091Koronis 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.
PubMed 30858697Massa 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.
PubMed 31571815
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Macular Edema in a Uveitis Population of 1500 Patients
- ClinicalTrials.gov ID
- NCT06686641
- Acronym / sponsor ID
- ML45555
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,550 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Nov 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-infectious uveitis patients treated at a hospitals in the North Denmark Region | – | Drug: Local and systemical treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Local and systemical treatmentEvaluating 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. | Drug | Non-infectious uveitis patients treated at a hospitals in the North Denmark Region |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- BackgroundØrskov et al. J Pers Med. 2023 8;13(6):970
- Background: PubMed 37440091Xue 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.
- Background: PubMed 30858697Koronis 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.
- Background: PubMed 31571815Massa 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.
- Individual participant dataSharing planned: No
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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.
Lasse J Cehofski, MD, P.h.d principal investigator
Aalborg University Hospital
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 Macular Edema and Non-infectious Uveitis, run by Aalborg University Hospital 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2024. 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?
Results are not available in the source record.
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 Macular Edema in patients with Uveitis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06686641, which also lists 4 linked publications.
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 13 Nov 2024.