NCT06792422RecruitingPhase 4
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 18 Dec 2024
- Start date
- Jan 2025
- Primary completion date
- Aug 2028
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Diseases
- Glaucoma
- NCT number
- NCT06792422
- EU CT number
- 2024-518510-87-00
- EudraCT number
- 2022-004142-35
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 126
- From Jan 2025 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intraocular surgery 3 months before inclusion
- Previous history of pancreatitis
- Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants
Other illness
- Diabetes or renal impairment
- Medical history of significant eye disease (including ocular trauma) other than glaucoma
- Ocular inflammation/infection within three months from inclusion
- Subjects allergic to drug ingredients administered during the trial
- Subjects with untreated severe systemic disease or malignancies
Other
- 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
- BMI \< 18.5
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.