E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
mild and moderate glaucoma |
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E.1.1.1 | Medical condition in easily understood language |
mild and moderate glaucoma |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036719 |
E.1.2 | Term | Primary open angle glaucoma |
E.1.2 | System Organ Class | 100000004853 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to investigate if Rybelsus has a beneficial effect on glaucoma patients. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 mild to moderate POAG, MD ≤ 12 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
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E.4 | Principal exclusion criteria |
• Diabetes or renal impairment • Moderate or severe age-related macular degeneration • 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 • Subjects allergic to drug ingredients administered during the trial • Subjects with severe systemic disease or malignancies • BMI < 18.5
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of whether semaglutide can improve the inner retinal function: Change in inner retinal function will be assessed by mean change in PhNR of the ERG between baseline and month 6. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Assessment of whether semaglutide can prevent functional glaucoma progression: Functional glaucoma progression will be assessed using standard automated perimetry and the Pelli-Robson chart contrast sensitivity test. Perimetry measures the change in mean deviation (MD). Contrast sensitivity assesses how well a person can distinguish an object from its background.
Assessment of whether semaglutide can reduce structural loss: Structural changes in the retina will be assessed by optical coherence tomography (OCT) (ring and macular scan). Ring scan OCT measures the RNFL thickness, the layer formed by the RGC axons, and macular OCT measures the number/volume of RGCs.
Assessment of the significance of semaglutide treatment for HRQoL: HRQoL will be assessed using two standardized validated questionnaires administered in Danish; the European Quality of life – 5 Dimensions – 3 Levels (EQ-5D-3L) questionnaire and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Assessment of safety and tolerance in semaglutide treatment: Safety and tolerance of oral semaglutide treatment in patients with glaucoma will be assessed by incidence of treatment-induced adverse events (TEAEs) and changes in safety-related blood analysis.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |