Evaluation of the Effects of Anti-TNF Therapy on the Retina in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 53 people enrolled
- Started
- 25 Nov 2025
- Ended
- 23 Jun 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Anti-TNF Therapy
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Age 18 to 75 years
- Diagnosis of rheumatoid arthritis or ankylosing spondylitis
- Receiving treatment for RA or AS (conventional therapy, planned initiation of anti-TNF therapy, or continued conventional non-biologic therapy)
- Willingness to participate and written informed consent
Who cannot take part
- • History of retinal disease (e.g., diabetic retinopathy, age-related macular degeneration, retinal vein occlusion); Ocular disease that may affect OCT measurements or visual field, such as glaucoma, optic neuropathy or dense cataract; Uveitis, diabetes mellitus or systemic hypertension; Previous ocular surgery or laser treatment, or high refractive error; Pregnancy or breastfeeding; Treatment with non-TNF biologic agents (e.g., abatacept, rituximab); OCTA scan quality (Q) score below 6
This trial has no sites in United States.
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About the trial
What the trial wants to find out
This prospective observational cohort study evaluates whether anti-tumor necrosis factor (anti-TNF) therapy changes the retinal and choroidal microvasculature and retinal structure in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Patients for whom the rheumatology clinic decided to start anti-TNF therapy as part of routine care are compared with patients who continue treatment without anti-TNF agents. All participants undergo a complete eye examination, optical coherence tomography (OCT) and OCT angiography (OCTA) before treatment and at month 6. The main question is whether retinal vessel density changes differently over time between the two groups.
The 2 groups in the trial
- Anti-TNF group
Anti-TNF-naive patients with RA or AS for whom the treating rheumatologist planned to start anti-TNF therapy as part of routine care. The baseline examination was performed before the first dose.
Treatment: Anti-TNF Therapy
- Control group
Patients with RA or AS who were not receiving anti-TNF therapy at baseline and did not start it during the 6-month follow-up. They continued conventional (non-biologic) treatment.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EVALUATION OF THE EFFECTS OF ANTI-TNF THERAPY ON THE RETINA IN PATIENTS WITH RHEUMATOID ARTHRITIS AND ANKYLOSING SPONDYLITIS
- Record updated
- 12 November 2026