Status:
RECRUITING
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Primary Open Angle Glaucoma (POAG)
Open-Angle Glaucoma
Eligibility:
All Genders
45+ years
Phase:
PHASE4
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06792422
Start Date
January 1 2025
End Date
December 1 2028
Last Update
January 24 2025
Active Locations (1)
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1
Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, Denmark, 2600