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Ocular Changes in Patients Using Tirzepatide or Semaglutide

3. november 2026 oppdatert av: Derya Budak Behrad, Istanbul University

Evaluation of Optic Nerve Head, Retinal Changes, and Choroidal Blood Flow in Patients With Diabetes and Obesity Using Tirzepatide or Semaglutide

This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.

Participants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods.

The study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This prospective observational cohort study will evaluate ocular structural and microvascular changes in adults with obesity receiving semaglutide or tirzepatide as part of routine clinical care. Participants will include individuals with and without type 2 diabetes mellitus.

The study population will be divided into four observational cohorts according to diabetes status and medication use:

  • Participants with obesity and type 2 diabetes receiving semaglutide.
  • Participants with obesity and type 2 diabetes receiving tirzepatide.
  • Participants with obesity without type 2 diabetes receiving semaglutide.
  • Participants with obesity without type 2 diabetes receiving tirzepatide.

Participants will undergo ophthalmologic examinations at baseline and during follow-up for up to 18 months. Assessments will include visual acuity, slit-lamp examination, intraocular pressure measurement, fundus examination, optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and enhanced depth imaging optical coherence tomography (EDI-OCT).

The study will evaluate changes in retinal nerve fiber layer thickness, retinal thickness, superficial and deep retinal vessel density, foveal avascular zone area, choriocapillaris flow deficit percentage, and choroidal thickness. Changes in visual acuity and intraocular pressure will also be assessed.

Ocular measurements obtained at baseline and during follow-up will be compared to investigate structural and microvascular changes associated with semaglutide or tirzepatide treatment. Differences between the observational cohorts may also be evaluated.

All medications will be prescribed by the treating physicians as part of routine clinical care. Treatment selection will not be determined by the study protocol, and no experimental ophthalmologic intervention will be performed.

Studietype

Observasjonsmessig

Registrering (Antatt)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34093
        • Rekruttering
        • Istanbul University, Istanbul Faculty of Medicine
        • Ta kontakt med:
        • Ta kontakt med:
          • ADEM TELLIOGLU, MD
          • Telefonnummer: +90 5066107361

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care will be included. Participants will include individuals with and without type 2 diabetes mellitus. The study population will be evaluated in four observational cohorts according to diabetes status and medication: obesity with diabetes receiving semaglutide, obesity with diabetes receiving tirzepatide, obesity without diabetes receiving semaglutide, and obesity without diabetes receiving tirzepatide.

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of obesity
  • Receiving semaglutide or tirzepatide as part of routine clinical care
  • Participants with or without type 2 diabetes mellitus
  • Availability for baseline and follow-up ophthalmologic examinations

Exclusion Criteria:

  • Age under 18 years
  • Not receiving semaglutide or tirzepatide
  • Inability to complete the required ophthalmologic examinations or imaging assessments

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Obesity With Diabetes - Semaglutide

Participants with obesity and diabetes receiving semaglutide as part of routine clinical care.
Legemiddel: Semaglutide

Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity With Diabetes - Tirzepatide

Participants with obesity and diabetes receiving tirzepatide as part of routine clinical care
Legemiddel: Tirzepatide

Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity Without Diabetes - Semaglutide

Participants with obesity without diabetes receiving semaglutide as part of routine clinical care
Legemiddel: Semaglutide

Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity Without Diabetes - Tirzepatide

Participants with obesity without diabetes receiving tirzepatide as part of routine clinical care
Legemiddel: Tirzepatide

Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Retinal Nerve Fiber Layer Thickness
Tidsramme: Baseline to up to 18 months

Change in retinal nerve fiber layer thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
Baseline to up to 18 months
Change in Retinal Thickness
Tidsramme: Baseline to up to 18 months

Change in retinal thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
Baseline to up to 18 months
Change in Superficial Retinal Vessel Density
Tidsramme: Baseline to 18 months

Change in superficial retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months
Change in Deep Retinal Vessel Density
Tidsramme: Baseline to 18 months

Change in deep retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months
Change in Foveal Avascular Zone Area
Tidsramme: Baseline to 18 months

Change in foveal avascular zone (FAZ) area from baseline to follow-up, measured using optical coherence tomography angiography (OCT-A) and expressed in square millimeters (mm²).
Baseline to 18 months
Change in Choriocapillaris Flow Deficit Percentage
Tidsramme: Baseline to 18 months

Change in choriocapillaris flow deficit percentage from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Visual Acuity
Tidsramme: Baseline to up to 18 months

Change in visual acuity from baseline during follow-up
Baseline to up to 18 months
Change in Intraocular Pressure
Tidsramme: Baseline to up to 18 months

Change in intraocular pressure from baseline during follow-up, measured in mmHg during routine ophthalmologic examination.
Baseline to up to 18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istanbul University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2026

Primær fullføring (Antatt)

17. september 2027

Studiet fullført (Antatt)

17. september 2027

Datoer for studieregistrering

Først innsendt

28. oktober 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025/2444

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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