Non-arteritic Anterior Ischemic Optic Neuropathy ObesityNCT07846956
NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
An observational study of Non-arteritic Anterior Ischemic Optic Neuropathy Obesity and Obesity, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-arteritic Anterior Ischemic Optic Neuropathy Obesity, Obesity
- What is being tested?
- GLP-1 Receptor Agonist Therapy
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2026to 30 Nov 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
- Not meeting the inclusion criteria or not willing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
About this study
Official title: Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) in Non-Diabetic Obese Patients Using Glucagon-Like Peptide-1 Receptor Agonists: A Retrospective Real-World Study
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.
Read the detailed description
Background and rationale: NAION results from impaired perfusion of the optic nerve head, and risk is increased by type 2 diabetes, hypertension, sleep apnea and a small optic disc ("disc at risk"). Proposed mechanisms linking GLP-1 RA to NAION include rapid glycemic and weight change affecting optic nerve perfusion autoregulation, direct effects through GLP-1 receptors present in the retinal ganglion cell layer, and nocturnal hypotension. Studies that examine GLP-1 RA use and NAION together in non-diabetic obese patients were not identified in the literature review by the investigators.
Design: Retrospective descriptive study. Data will be collected by the investigators from the hospital information system; no new examination, parameter or intervention will be requested from patients. Data collection is planned from 30 May 2026 to 30 November 2026, after ethics committee and hospital approval.
Data collected: Age, education level, smoking, alcohol use, weight, height and BMI; ophthalmic findings including Snellen visual acuity, biomicroscopic anterior segment examination, intraocular pressure, fundus examination, direct/indirect light reflex, and retinal nerve fiber layer thickness measured by OCT. Data are recorded on a Descriptive Information Form developed by the investigators.
Sample size: Because no sampling will be performed, all patients meeting the criteria will be included. A power analysis using proportions of 0.38 and 0.09 from previous studies (95% confidence, alpha 0.05, 80% power) gave a required sample of 28 participants.
Statistical analysis: IBM SPSS 26.0. Descriptive statistics (number, percentage, mean, standard deviation); normality by Shapiro-Wilk test, skewness and kurtosis; t-test and/or Mann-Whitney U for two-group comparisons; ANOVA and/or Kruskal-Wallis H for three or more groups; correlation and/or chi-square analysis for associations. Significance level p < 0.05 with 95% confidence interval.
Confidentiality: Personal information of patients will be kept confidential.
- Being tested
- GLP-1 Receptor Agonist Therapy
- Keywords
- NAION, GLP-1 receptor agonist, semaglutide, tirzepatide, obesity, non-diabetic, optic neuropathy
- Medical subject headings
- Obesity, Optic Neuropathy, Ischemic, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Receptor Agonist TherapyDrug
Use of a GLP-1 RA prescribed in routine clinical care. No study-specific treatment is given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GLP-1 Receptor Agonist Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of NAION
Number and percentage of participants with a NAION diagnosis recorded in the ophthalmic examination records.
Measured: 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
Change in Snellen best-corrected visual acuity between the first and last recorded ophthalmic examination during the study period.
Measured: Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-arteritic Anterior Ischemic Optic Neuropathy ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLDEN ANATACA, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846956
- Sponsor's protocol ID
- KAEK/2026.04.200
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38958939Liu 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.
PubMed 37013752Kapoor 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.
PubMed 37454782Allan 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.
PubMed 39863057Aroda 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.
PubMed 36700417
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) in Non-Diabetic Obese Patients Using Glucagon-Like Peptide-1 Receptor Agonists: A Retrospective Real-World Study
- ClinicalTrials.gov ID
- NCT07846956
- Acronym / sponsor ID
- KAEK/2026.04.200
- Keywords
- NAION, GLP-1 receptor agonist, semaglutide, tirzepatide, obesity, non-diabetic, optic neuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale: NAION results from impaired perfusion of the optic nerve head, and risk is increased by type 2 diabetes, hypertension, sleep apnea and a small optic disc ("disc at risk"). Proposed mechanisms linking GLP-1 RA to NAION include rapid glycemic and weight change affecting optic nerve perfusion autoregulation, direct effects through GLP-1 receptors present in the retinal ganglion cell layer, and nocturnal hypotension. Studies that examine GLP-1 RA use and NAION together in non-diabetic obese patients were not identified in the literature review by the investigators.
Design: Retrospective descriptive study. Data will be collected by the investigators from the hospital information system; no new examination, parameter or intervention will be requested from patients. Data collection is planned from 30 May 2026 to 30 November 2026, after ethics committee and hospital approval.
Data collected: Age, education level, smoking, alcohol use, weight, height and BMI; ophthalmic findings including Snellen visual acuity, biomicroscopic anterior segment examination, intraocular pressure, fundus examination, direct/indirect light reflex, and retinal nerve fiber layer thickness measured by OCT. Data are recorded on a Descriptive Information Form developed by the investigators.
Sample size: Because no sampling will be performed, all patients meeting the criteria will be included. A power analysis using proportions of 0.38 and 0.09 from previous studies (95% confidence, alpha 0.05, 80% power) gave a required sample of 28 participants.
Statistical analysis: IBM SPSS 26.0. Descriptive statistics (number, percentage, mean, standard deviation); normality by Shapiro-Wilk test, skewness and kurtosis; t-test and/or Mann-Whitney U for two-group comparisons; ANOVA and/or Kruskal-Wallis H for three or more groups; correlation and/or chi-square analysis for associations. Significance level p < 0.05 with 95% confidence interval.
Confidentiality: Personal information of patients will be kept confidential.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RA users (non-diabetic, obese) | – | Drug: GLP-1 Receptor Agonist TherapyAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Not meeting the inclusion criteria or not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 Receptor Agonist TherapyUse of a GLP-1 RA prescribed in routine clinical care. No study-specific treatment is given. | Drug | GLP-1 RA users (non-diabetic, obese) |
Primary outcome
Occurrence of NAION
Time frame: Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months
Number and percentage of participants with a NAION diagnosis recorded in the ophthalmic examination records.
1 secondary outcome
• Change in visual acuity (Snellen chart) between the first and last recorded examination
Time frame: Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 38958939Hathaway 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.
- Background: PubMed 37013752Liu 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.
- Background: PubMed 37454782Kapoor 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.
- Background: PubMed 39863057Allan 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.
- Results publication: PubMed 36700417Aroda 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-arteritic Anterior Ischemic Optic Neuropathy Obesity and Obesity, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÜLDEN ANATACA (05059284244, ganataca@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of NAION (time frame: Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07846956, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.