NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study

NCT07846956 | Not Yet Recruiting

• 1 other identifier: KAEK/2026.04.200
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy Obesity; Obesity

Keywords

NAION; GLP-1 receptor agonist; semaglutide; tirzepatide; obesity; non-diabetic; optic neuropathy

Outcome Measures

Primary Outcomes (1)

• Occurrence of NAION

  Number and percentage of participants with a NAION diagnosis recorded in the ophthalmic examination records.

  Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months

Secondary Outcomes (1)

• • Change in visual acuity (Snellen chart) between the first and last recorded examination

  Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months

Study Arms (1)

GLP-1 RA users (non-diabetic, obese)

Adults aged 18 or older with BMI \> 30 and no diabetes diagnosis, who used a GLP-1 receptor agonist and had at least two ophthalmic examinations with measurements at the clinic between January 2025 and February 2026.

Drug: GLP-1 Receptor Agonist Therapy

Interventions

GLP-1 Receptor Agonist Therapy DRUG

Use of a GLP-1 RA prescribed in routine clinical care. No study-specific treatment is given.

GLP-1 RA users (non-diabetic, obese)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• At least two eye examinations with measurements on record
• Verbal agreement to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Hathaway JT, Shah MP, Hathaway DB, Zekavat SM, Krasniqi D, Gittinger JW Jr, Cestari D, Mallery R, Abbasi B, Bouffard M, Chwalisz BK, Estrela T, Rizzo JF 3rd. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmol. 2024 Aug 1;142(8):732-739. doi: 10.1001/jamaophthalmol.2024.2296.

  PMID: 38958939 BACKGROUND

• Liu H, Zhang JT, Xin SH, Ren WN, Lu QK. Comprehensive review of glucagon-like peptide 1 receptor agonist treatment on the risk of cardiovascular outcomes and retinopathy as diabetic complications. Eur Rev Med Pharmacol Sci. 2023 Mar;27(6):2332-2340. doi: 10.26355/eurrev_202303_31768.

  PMID: 37013752 BACKGROUND

• Kapoor I, Sarvepalli SM, D'Alessio D, Grewal DS, Hadziahmetovic M. GLP-1 receptor agonists and diabetic retinopathy: A meta-analysis of randomized clinical trials. Surv Ophthalmol. 2023 Nov-Dec;68(6):1071-1083. doi: 10.1016/j.survophthal.2023.07.002. Epub 2023 Jul 16.

  PMID: 37454782 BACKGROUND

• Allan KC, Joo JH, Kim S, Shaia J, Kaelber DC, Singh R, Talcott KE, Rachitskaya AV. Glucagon-like Peptide-1 Receptor Agonist Impact on Chronic Ocular Disease Including Age-Related Macular Degeneration. Ophthalmology. 2025 Jul;132(7):748-757. doi: 10.1016/j.ophtha.2025.01.016. Epub 2025 Jan 23.

  PMID: 39863057 BACKGROUND

• Aroda VR, Erhan U, Jelnes P, Meier JJ, Abildlund MT, Pratley R, Vilsboll T, Husain M. Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. 2023 May;25(5):1385-1397. doi: 10.1111/dom.14990. Epub 2023 Feb 21.

  PMID: 36700417 RESULT

MeSH Terms

Conditions

Obesity; Optic Neuropathy, Ischemic; Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

GÜLDEN ANATACA

CONTACT

05059284244; ganataca@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsD,RN

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

TU (1)