NCT07113834

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

August 3, 2025

Last Update Submit

August 3, 2025

Conditions

Keywords

Ankylosing SpondylitisUveitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 3-month follow-up

Interventions

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.

Oral or intravenous corticosteroids (e.g., prednisolone) used to suppress systemic inflammation in cases of active AS or severe uveitis.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Cairo Governorate, 13111, Egypt

Location

MeSH Terms

Conditions

UveitisSpondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 11, 2025

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

August 1, 2024

Last Updated

August 11, 2025

Record last verified: 2023-09

Locations