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

NCT06792422 · Glostrup University Hospital, Copenhagen
In plain English

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Official title
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
About this study
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-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
Study design
Enrollment target: 126 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-01
Estimated completion: 2028-12
Last updated: 2025-01-24
Interventions
Drug: Oral semaglutideDrug: Placebo
Primary outcomes
  • Photopic negative response of the electroretinogram after 6 months (From baseline to month 6.)
Sponsor
Glostrup University Hospital, Copenhagen · other
Contacts & investigators
ContactMiriam Kolko, MD, PhD · contact · miriamk@sund.ku.dk · +45 29807667
ContactAnna-Sophie Thein · contact · anna-sophie.thein@sund.ku.dk
All locations (1)
Department of Ophthalmology, RigshospitaletRecruiting
Glostrup Municipality, Denmark
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma · TrialPath