NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul Saglik Bilimleri University
About this trial
Non-arteritic anterior ischemic optic neuropathy (NAION) is one of the most common causes of sudden, painless, usually unilateral vision loss in adults over 50 years of age, and no proven effective treatment exists. Glucagon-like peptide-1 receptor agonists (GLP-1 RA), such as semaglutide and tirzepatide, are widely used for type 2 diabetes and obesity. Since 2023, case series, cohort studies and regulatory reviews have raised the possibility of an association between semaglutide and NAION, but published evidence is conflicting, and data in non-diabetic obese patients are limited.
This retrospective, single-center, descriptive real-world study will review the existing records of non-diabetic obese adults (BMI \> 30) who used a GLP-1 RA and attended the ophthalmology outpatient clinic between January 2025 and February 2026 with at least two eye examinations. The aim is to describe the occurrence and time-related change of NAION and related ophthalmic findings in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of obesity (body mass index > 30)
No hearing, speech or cognitive impairment
Not receiving treatment for major depressive disorder and not using antidepressant medication
Disqualifiers
Diagnosis of hypertension
Previous optic neuritis or similar eye disease
Optic disc drusen, optic disc anomaly, glaucoma or other disease involving the optic nerve
High hyperopia or small, crowded optic disc
Trial population
Non-diabetic obese adults using a GLP-1 receptor agonist who attended the ophthalmology outpatient clinic of Kanuni Sultan Suleyman Training and Research Hospital between January 2025 and February 2026.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GLP-1 Receptor Agonist Therapy
DrugUse of a GLP-1 RA prescribed in routine clinical care. No study-specific treatment is given.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: GLP-1 RA users (non-diabetic, obese)1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of NAION
Number and percentage of participants with a NAION diagnosis recorded in the ophthalmic examination records.
Time frame
Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 monthsSecondary outcomes
1
• Change in visual acuity (Snellen chart) between the first and last recorded examination
Change in Snellen best-corrected visual acuity between the first and last recorded ophthalmic examination during the study period.
Time frame
Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 monthsSponsors and contacts
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Source ClinicalTrials.gov
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