ClinicalTrials.gg
CompletedNCT07931352Updated Nov 12, 2026

Evaluation of the Effects of Anti-TNF Therapy on the Retina in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

An observational study in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Ankara City Hospital Bilkent · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 127 studies in Arthritis, Rheumatoid with a site in Turkey — 14 open to participants now, 19 under way, 2 of them phase 3. Arthritis, Rheumatoid · Turkey.

Enrollment
43rd of 50
53 · median 100
Started
2025
with 17 others
Observational
50 of 127
9 open now
Registered
127th of 127
by date

Among the 127 studies in Arthritis, Rheumatoid with a site in Turkey, this one is the 43rd largest by enrollment of the 50 observational ones that give a count, is one of 18 that started in 2025, is one of 50 observational ones, and was the 127th registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

14 of the 127 studies in Arthritis, Rheumatoid with a site in Turkey are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

Background: Chronic systemic inflammation in RA and AS has been associated with endothelial dysfunction and microvascular changes. TNF-alpha is a key mediator of this inflammation, and anti-TNF agents are widely used in both diseases. Prospective data on retinal and choroidal microvasculature with measurements taken before the start of anti-TNF therapy are limited.

Design and participants: Patients with RA or AS followed at the Rheumatology Clinic of Ankara Bilkent City Hospital were referred to the Ophthalmology Clinic between October and December 2025. Treatment decisions were made by the treating rheumatologists, independently of the study. The anti-TNF group consists of anti-TNF-naive patients for whom anti-TNF therapy was planned; their baseline examination was performed before the first dose. The control group consists of patients who were not receiving anti-TNF therapy at baseline and did not start it during the 6-month follow-up.

Assessments: At baseline and month 6, all participants undergo best-corrected visual acuity (logMAR), Goldmann applanation tonometry, slit-lamp biomicroscopy and dilated fundus examination with a +90 D lens. OCT (Heidelberg Spectralis) is used to measure central and sectoral macular thickness, peripapillary retinal nerve fiber layer (RNFL) thickness (global and six sectors) and ganglion cell layer (GCL) thickness. OCTA (RTVue XR Avanti with AngioVue, Optovue) is performed with fovea-centred 6x6 mm scans. Superficial (SCP) and deep capillary plexus (DCP) vessel density are recorded for the whole image, superior and inferior hemifields, and foveal, parafoveal and perifoveal regions with four sectors. Foveal avascular zone (FAZ) area, FAZ perimeter, acircularity index, foveal vessel density and choriocapillaris flow area are also recorded. 3D projection artifact removal is applied. Scans with a quality (Q) score below 6, significant motion or projection artifacts, or segmentation errors are excluded. All examinations are performed by the same, unmasked examiner. ESR and CRP values closest to each visit are obtained from hospital records.

Statistical analysis: Eye-level data are analysed with linear mixed models adjusted for age and sex. The treatment effect is assessed by the group-by-time interaction. The study is reported according to the STROBE guideline.

03

Conditions studied

  • Rheumatoid Arthritis (RA)
  • Ankylosing Spondylitis (AS)

Keywords

  • optical coherence tomography
  • optical coherence tomography angiography
  • tumor necrosis factor
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with rheumatoid arthritis or ankylosing spondylitis followed at the Rheumatology Clinic of Ankara Bilkent City Hospital and referred to the Ophthalmology Clinic between October and December 2025.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

    • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: 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.

Interventions

  • DrugAnti-TNF Therapy

    adalimumab, etanercept, golimumab

    Also known as: TNF inhibitor prescribed by the treating rheumatologist according to routine clinical practice; not assigned by the study protocol.

06

What researchers measure

Primary outcomes

  1. Change in superficial capillary plexus whole-image vessel density

    SCP vessel density (%) in fovea-centred 6x6 mm OCTA scans (AngioVue, Optovue). Change from baseline to month 6 is compared between groups (group-by-time interaction).

    Time frame: Baseline and month 6

  2. Change in deep capillary plexus whole-image vessel density

    DCP vessel density (%) in fovea-centred 6x6 mm OCTA scans. Change from baseline to month 6 is compared between groups.

    Time frame: Baseline and month 6

Secondary outcomes

  1. Erythrocyte sedimentation (mm/h) rate

    Change in systemic inflammatory marker obtained from hospital records.

    Time frame: Baseline and month 6

  2. C-reactive protein (mg/L) value

    Change in systemic inflammatory marker obtained from hospital records.

    Time frame: Baseline and month 6

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared publicly. Aggregate results will be reported in scientific publications.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2025 to primary completion in Jun 2026, 6 months.

Of 236 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 122. This study's 6 months is below that.

Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Nov 12, 2026
StartActual
Nov 25, 2025
Primary completionActual
Jun 23, 2026
CompletionActual
Jun 23, 2026
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931352
Responsible party
Muhammet Ali Gürsoy (Medical Doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 25, 2025
Primary completion
Jun 23, 2026
Completion
Jun 23, 2026
Last update
Nov 12, 2026

Study contacts

Yasin Toklu, Professor Doctor
study director · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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