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

RecruitingPhase 4Ages 45 Years - anyAllGlostrup University Hospital, Copenhagen
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner; Sexual abstinence * Subjects allergic to drug ingredients administered during the trial * Subjects with untreated severe systemic disease or malignancies * Previous history of pancreatitis * BMI \< 18.5 * Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants
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What it tests

  • Oral semaglutide
  • Placebo
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Where

1 site
Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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