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Recruiting NCT06792422

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

Phase IV Interventional Primary Open Angle Glaucoma (POAG) Open-Angle Glaucoma Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral semaglutide, Placebo.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma (POAG), Open-Angle Glaucoma, Glaucoma. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Oral semaglutide
    Participants 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 Placebo
    Participants 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)

Primary outcome measures

  • Photopic negative response of the electroretinogram after 6 months [Time frame: From baseline to month 6.]
Secondary outcome measures (5)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Ophthalmology, Rigshospitalet — Glostrup Municipality

Identifiers

NCT: NCT06792422 · 97669 · NNF22OC0079544 · 2024-518510-87-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗