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Recruiting Phase 4 NCT06792422

NCT06792422 A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma

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Clinical Trial Summary
NCT ID NCT06792422
Status Recruiting
Phase Phase 4
Sponsor Glostrup University Hospital, Copenhagen
Condition Primary Open Angle Glaucoma (POAG)
Study Type INTERVENTIONAL
Enrollment 126 participants
Start Date 2025-01
Primary Completion 2028-08

Trial Parameters

Condition Primary Open Angle Glaucoma (POAG)
Sponsor Glostrup University Hospital, Copenhagen
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 126
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2025-01
Completion 2028-08
Interventions
Oral semaglutidePlacebo

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Brief Summary

The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. The main question it aims to answer is: Does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram. Researchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug). Participants will: * Take semaglutide or a placebo every day for 6 months. * Visit the clinic 5 times in total for tests and interviews: At baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).

Eligibility Criteria

Inclusion Criteria: * Ability to read and speak Danish * 45 years or older at the time of inclusion * Visual acuity equal to or above 0.5 in the study eye * Diagnosis of POAG with MD ≤ 16 dB with repeatable and reliable (false positive less than 15 %) VF loss measured by standard automated perimetry on at least one eye * Receiving IOP-lowering glaucoma treatment * Nerve fiber layer defects identified by OCT Exclusion Criteria: * Diabetes or renal impairment * Medical history of significant eye disease (including ocular trauma) other than glaucoma * Ocular inflammation/infection within three months from inclusion * Intraocular surgery 3 months before inclusion * Smoker at the time of inclusion * Pregnant or breast-feeding * Females of childbearing potential who are not using adequate contraceptive, which includes the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-on

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