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NCT Number: NCT06792422

A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma

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).

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Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Open-angle Glaucoma

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location status: Recruiting

Location contact

Miriam Kolko, MD, PhD, Professor, Consultant

CONTACT

[email protected]

+45 29807667

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 criteria

  • 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

Treatment and study plan

Oral semaglutide

Drug

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)

Placebo

Drug

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Photopic negative response of the electroretinogram after 3 months

    Time frame: From baseline to month 3.

    Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.

  2. Pelli-Robson chart contrast sensitivity test

    Time frame: From baseline to month 6.

    Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.

  3. Health-related quality of life (HRQoL)

    Time frame: From baseline to month 6.

    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.

  4. Health-related quality of life (HRQoL)

    Time frame: From baseline to month 6.

    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.

  5. Number of treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: From baseline to month 6.

    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.

Other outcomes

  1. Optical coherence tomography (OCT), ring scan

    Time frame: From baseline to month 6.

    Structural glaucoma progression assessed by the OCT ring scan, which measures the retinal nerve fibre layer thickness.

  2. Optical coherence tomography (OCT), macular scan

    Time frame: From baseline to month 6.

    Structural glaucoma progression assessed by the OCT macular scan which measures the volume of retinal ganglion cells.

  3. Standard automated perimetry

    Time frame: From baseline to month 6.

    Visual field loss will be evaluated using standard automated perimetry. Progression will be measured by changes in mean deviation (MD).

  4. Multi-omics

    Time frame: From baseline to month 6.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Sophie Thein

CONTACT

[email protected]

Miriam Kolko, MD, PhD

CONTACT

[email protected]

+45 29807667

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection

Acronym: ABSALON

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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