UveitisuveitisNCT07113834
Characteristics of Ankylosing Spondylitis Associated Uveitis
An observational study of Uveitis, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to understand the clinical characteristics associated with AAU in Egyptian AS patients, and the prognostic factors, in terms of the Corrected Distance Visual Acuity (CDVA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis
- What is being tested?
- Adalimumab and Systemic corticosteroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Aug 2024
- 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: This study included a retrospective cohort of 22 Egyptian patients (26 eyes) diagnosed with Ankylosing Spondylitis-associated Acute Anterior Uveitis (ASAAU), who were referred to the Ophthalmology Clinics of Benha University - Faculty of Medicine from the Spine Clinic at the same institution between September 2023 and August 2024. The cohort was composed of adult patients who met the Modified New York Criteria for AS and had documented ophthalmic symptoms confirmed as AAU through clinical and imaging evaluation. All included patients had complete follow-up data and received appropriate treatment for both AS and uveitis.
Who may be able to join
- Egyptian nationality.
- Age: ≥ 18 years.
- Confirmed diagnosis of Ankylosing Spondylitis (AS) according to the Modified New York Criteria, including:
- Clinical symptoms (e.g., chronic inflammatory back pain, reduced lumbar motion, reduced chest expansion)
- Radiographic evidence of sacroiliitis.
- Confirmed diagnosis of Acute Anterior Uveitis (AAU) based on:
Show all 12Show fewer
- Ophthalmologic examination (e.g., slit-lamp biomicroscopy)
- Ancillary testing (e.g., Optical Coherence Tomography [OCT] and/or Fluorescein Angiography [FA]).
- Presentation to the Spine Clinic of Benha University - Faculty of Medicine between September 2023 and August 2024 with ophthalmic complaints, subsequently referred to the Ophthalmology Clinic.
- Complete medical and ophthalmologic records available.
- Received treatment for both AS and AAU.
- At least one follow-up visit after initiation of treatment.
Who cannot join
- Non-Egyptian patients.
- History of other systemic autoimmune or immunological diseases (e.g., sarcoidosis, Behçet's disease, systemic lupus erythematosus).
- Uveitis due to non-autoimmune secondary causes (e.g., infectious uveitis, trauma-related uveitis).
- History of ocular surgery prior to the episode of AAU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Ankylosing Spondylitis Associated Uveitis: A Retrospective Study in Egyptian Patients
This study aims to understand the clinical characteristics associated with AAU in Egyptian AS patients, and the prognostic factors, in terms of the Corrected Distance Visual Acuity (CDVA).
Read the detailed description
This is a one-year retrospective cohort study conducted at the Spine and Ophthalmology Clinics of Benha University - Faculty of Medicine, Egypt, between September 2023 and August 2024. The study aims to characterize the clinical features and identify prognostic factors affecting visual outcomes in patients with Ankylosing Spondylitis-associated Anterior Uveitis (ASAAU).
Patients included in this study were Egyptian nationals who initially presented to the Spine Clinic with systemic symptoms of ankylosing spondylitis (AS) and were subsequently referred to the Ophthalmology Clinic due to ophthalmic complaints. Only patients who were confirmed to have both AS (diagnosed according to the Modified New York criteria and radiographic imaging) and anterior uveitis (confirmed by slit-lamp examination and supported by Optical Coherence Tomography [OCT] and Fluorescein Angiography [FA]) were enrolled.
The final sample included 26 eyes from 22 patients who fulfilled the inclusion criteria. Patients were excluded if they were non-Egyptian, had other systemic autoimmune or immunologic conditions, had uveitis due to secondary causes, had undergone ocular surgeries, did not receive uveitis treatment, were lost to follow-up, or had incomplete medical records.
- Conditions
- Uveitis
- Being tested
- Adalimumab, Systemic corticosteroids
- Keywords
- Ankylosing Spondylitis, Uveitis
- Medical subject headings
- Uveitis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
A tumor necrosis factor-alpha (TNF-α) inhibitor used as a biologic agent for the treatment of ankylosing spondylitis. Administered subcutaneously as part of systemic immunomodulatory therapy.
Systemic corticosteroidsDrug
Oral or intravenous corticosteroids (e.g., prednisolone) used to suppress systemic inflammation in cases of active AS or severe uveitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corrected Distance Visual Acuity (CDVA)
CDVA was assessed at baseline (initial presentation) and after treatment (follow-up average of 3 months), using the Logarithm of the Minimum Angle of Resolution (logMAR) scale. Improvement or deterioration in CDVA was evaluated in relation to clinical characteristics, treatment modalities, and complication development.
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2023
- Primary completion1 Sep 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113834
- Sponsor's protocol ID
- Ankylosing
- Acronym
- uveitis
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Ankylosing Spondylitis Associated Uveitis: A Retrospective Study in Egyptian Patients
- ClinicalTrials.gov ID
- NCT07113834
- Acronym / sponsor ID
- uveitis / Ankylosing
- Conditions
- Uveitis
- Keywords
- Ankylosing Spondylitis, Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Aug 2025 (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.
This study aims to understand the clinical characteristics associated with AAU in Egyptian AS patients, and the prognostic factors, in terms of the Corrected Distance Visual Acuity (CDVA).
Detailed description
This is a one-year retrospective cohort study conducted at the Spine and Ophthalmology Clinics of Benha University - Faculty of Medicine, Egypt, between September 2023 and August 2024. The study aims to characterize the clinical features and identify prognostic factors affecting visual outcomes in patients with Ankylosing Spondylitis-associated Anterior Uveitis (ASAAU).
Patients included in this study were Egyptian nationals who initially presented to the Spine Clinic with systemic symptoms of ankylosing spondylitis (AS) and were subsequently referred to the Ophthalmology Clinic due to ophthalmic complaints. Only patients who were confirmed to have both AS (diagnosed according to the Modified New York criteria and radiographic imaging) and anterior uveitis (confirmed by slit-lamp examination and supported by Optical Coherence Tomography [OCT] and Fluorescein Angiography [FA]) were enrolled.
The final sample included 26 eyes from 22 patients who fulfilled the inclusion criteria. Patients were excluded if they were non-Egyptian, had other systemic autoimmune or immunologic conditions, had uveitis due to secondary causes, had undergone ocular surgeries, did not receive uveitis treatment, were lost to follow-up, or had incomplete medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included a retrospective cohort of 22 Egyptian patients (26 eyes) diagnosed with Ankylosing Spondylitis-associated Acute Anterior Uveitis (ASAAU), who were referred to the Ophthalmology Clinics of Benha University - Faculty of Medicine from the Spine Clinic at the same institution between September 2023 and August 2024. The cohort was composed of adult patients who met the Modified New York Criteria for AS and had documented ophthalmic symptoms confirmed as AAU through clinical and imaging evaluation. All included patients had complete follow-up data and received appropriate treatment for both AS and uveitis.
Key inclusion criteria (12 listed)
- Egyptian nationality.
- Age: ≥ 18 years.
- Confirmed diagnosis of Ankylosing Spondylitis (AS) according to the Modified New York Criteria, including:
- Clinical symptoms (e.g., chronic inflammatory back pain, reduced lumbar motion, reduced chest expansion)
- Radiographic evidence of sacroiliitis.
Key exclusion criteria (4 listed)
- Non-Egyptian patients.
- History of other systemic autoimmune or immunological diseases (e.g., sarcoidosis, Behçet's disease, systemic lupus erythematosus).
- Uveitis due to non-autoimmune secondary causes (e.g., infectious uveitis, trauma-related uveitis).
- History of ocular surgery prior to the episode of AAU
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 |
|---|---|---|
| AdalimumabA tumor necrosis factor-alpha (TNF-α) inhibitor used as a biologic agent for the treatment of ankylosing spondylitis. Administered subcutaneously as part of systemic immunomodulatory therapy. | Drug | – |
| Systemic corticosteroidsOral or intravenous corticosteroids (e.g., prednisolone) used to suppress systemic inflammation in cases of active AS or severe uveitis. | Drug | – |
Primary outcome
Change in Corrected Distance Visual Acuity (CDVA)
Time frame: Baseline and 3-month follow-up
CDVA was assessed at baseline (initial presentation) and after treatment (follow-up average of 3 months), using the Logarithm of the Minimum Angle of Resolution (logMAR) scale. Improvement or deterioration in CDVA was evaluated in relation to clinical characteristics, treatment modalities, and complication development.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Uveitis, run by Benha University at 1 site in Egypt.
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 12 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Corrected Distance Visual Acuity (CDVA) (time frame: Baseline and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.