Primary Open Angle Glaucoma (POAG)Phase 4ABSALONNCT06792422
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
A Phase 4 study testing Oral semaglutide in people with Primary Open Angle Glaucoma (POAG) and Open-Angle Glaucoma, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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 retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG), Open-Angle Glaucoma, Glaucoma
- What is being tested?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna-Sophie Thein contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, 2600
Miriam Kolko, MD, PhD, Professor, Consultant, +45 29807667, miriamk@sund.ku.dk
About this study
Official title: Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
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).
Read more
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).
- Being tested
- Oral semaglutide, Placebo
- Keywords
- Glaucoma, Semaglutide, Rybelsus, Primary Open Angle Glaucoma, GLP-1RA, Photopic Negative Response, GLP-1
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral semaglutideDrug
Participants will receive oral semaglutide once daily.
- Starting dose 3 mg/day for one month (day 1-28)
- Intermediate dose 7 mg/day for one month (day 29-56)
- Maintenance dose 14 mg/day (day 57-182)
PlaceboDrug
Participants will receive an oral placebo once daily.
- Placebo tablets received on visit 1 (baseline) for one month (day 1-28)
- Placebo tablets received on visit 2 (month 1) for one month (day 29-56)
- Placebo tablets received on visit 3 (month 2) for four months (day 57-182)
| Study group | Role | What they receive |
|---|---|---|
| Oral Semaglutide | Experimental | Participants are given oral semaglutide once daily. Receives: Drug: Oral semaglutide |
| Placebo | Placebo comparator | Participants are given oral placebo once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to month 6.
Secondary outcomes (5)
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.
Measured: From baseline to month 3.
Pelli-Robson chart contrast sensitivity test
Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Kolko, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792422
- Sponsor's protocol ID
- 97669
- Other IDs
- NNF22OC0079544, 2024-518510-87-00
- Acronym
- ABSALON
- Status last verified
- Nov 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
- ClinicalTrials.gov ID
- NCT06792422
- Acronym / sponsor ID
- ABSALON / 97669
- Keywords
- Glaucoma, Semaglutide, Rybelsus, Primary Open Angle Glaucoma, GLP-1RA, Photopic Negative Response, GLP-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Semaglutide | Experimental | Drug: Oral semaglutideParticipants are given oral semaglutide once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants are given oral placebo once daily. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral semaglutideParticipants will receive oral semaglutide once daily. 1. Starting dose 3 mg/day for one month (day 1-28) 2. Intermediate dose 7 mg/day for one month (day 29-56) 3. Maintenance dose 14 mg/day (day 57-182) | Drug | Oral Semaglutide |
| PlaceboParticipants will receive an oral placebo once daily. 1. Placebo tablets received on visit 1 (baseline) for one month (day 1-28) 2. Placebo tablets received on visit 2 (month 1) for one month (day 29-56) 3. Placebo tablets received on visit 3 (month 2) for four months (day 57-182) | Drug | Placebo |
Primary outcome
Photopic negative response of the electroretinogram after 6 months
Time frame: From baseline to month 6.
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.
5 secondary outcomes
Photopic negative response of the electroretinogram after 3 months
Time frame: From baseline to month 3.
Pelli-Robson chart contrast sensitivity test
Time frame: From baseline to month 6.
Health-related quality of life (HRQoL)
Time frame: From baseline to month 6.
Health-related quality of life (HRQoL)
Time frame: From baseline to month 6.
Number of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From baseline to month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna-Sophie Thein contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral semaglutide in people with Primary Open Angle Glaucoma (POAG) and Open-Angle Glaucoma, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Kolko, MD, PhD (+45 29807667, miriamk@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photopic negative response of the electroretinogram after 6 months (time frame: From baseline to month 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.