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| ID | Type | Description | Link |
|---|---|---|---|
| NNF22OC0079544 | Other Grant/Funding Number | The Novo Nordisk Foundation | |
| 2024-518510-87-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Semaglutide | Experimental | Participants are given oral semaglutide once daily. |
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| Placebo | Placebo Comparator | Participants are given oral placebo once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Participants will receive oral semaglutide once daily.
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| Measure | Description | Time Frame |
|---|---|---|
| Photopic negative response of the electroretinogram after 6 months | Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram. | From baseline to month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Photopic negative response of the electroretinogram after 3 months | Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram. | From baseline to month 3. |
| Pelli-Robson chart contrast sensitivity test |
| Measure | Description | Time Frame |
|---|---|---|
| Optical coherence tomography (OCT), ring scan | Structural glaucoma progression assessed by the OCT ring scan, which measures the retinal nerve fibre layer thickness. | From baseline to month 6. |
| Optical coherence tomography (OCT), macular scan |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miriam Kolko, MD, PhD | Contact | +45 29807667 | miriamk@sund.ku.dk | |
| Anna-Sophie Thein | Contact | anna-sophie.thein@sund.ku.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Rigshospitalet | Recruiting | Glostrup Municipality | 2600 | Denmark |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Drug | Participants will receive an oral placebo once daily.
|
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Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test. |
| From baseline to month 6. |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) assessed with the European Quality of life - 5 Dimensions - 3 Levels (EQ-5D-3L) questionnaire, a standardized validated questionnaire administered in Danish. The EQ-5D-3L questionnaire comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | From baseline to month 6. |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) assessed with the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25), a standardized validated questionnaire administered in Danish. The scoring system for the NEI VFQ-25 generates 12 subscale scores and an overall composite score. A higher score indicates a higher level of functioning. | From baseline to month 6. |
| Number of treatment-related adverse events as assessed by CTCAE v5.0 | Safety and tolerance of oral semaglutide treatment in patients with glaucoma assessed by the incidence of treatment-emergent adverse events (TEAEs) by CTCAE v5.0. | From baseline to month 6. |
Structural glaucoma progression assessed by the OCT macular scan which measures the volume of retinal ganglion cells.
| From baseline to month 6. |
| Standard automated perimetry | Visual field loss will be evaluated using standard automated perimetry. Progression will be measured by changes in mean deviation (MD). | From baseline to month 6. |
| Multi-omics | Changes in the cytokine proteome will be assessed by changes in concentrations of glaucoma-associated cytokines as related to inflammation. Changes in the metabolome and lipidome will be assessed by changes in plasma metabolomics and lipidomics. | From baseline to month 6. |