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

NCT06792422 | Recruiting Phase 4 DMC

• 3 other identifiers: 97669NNF22OC00795442024-518510-87-00
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Primary Open Angle Glaucoma (POAG); Open-Angle Glaucoma; Glaucoma

Keywords

Glaucoma; Semaglutide; Rybelsus; Primary Open Angle Glaucoma; GLP-1RA; Photopic Negative Response; GLP-1

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Photopic negative response of the electroretinogram after 3 months

  From baseline to month 3.

• Pelli-Robson chart contrast sensitivity test

  From baseline to month 6.

• Health-related quality of life (HRQoL)

  From baseline to month 6.

• Health-related quality of life (HRQoL)

  From baseline to month 6.

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

  From baseline to month 6.

Other Outcomes (4)

• Optical coherence tomography (OCT), ring scan

  From baseline to month 6.

• Optical coherence tomography (OCT), macular scan

  From baseline to month 6.

• Standard automated perimetry

  From baseline to month 6.

Study Arms (2)

Oral Semaglutide

EXPERIMENTAL

Participants are given oral semaglutide once daily.

Drug: Oral semaglutide

Placebo

PLACEBO COMPARATOR

Participants are given oral placebo once daily.

Drug: Placebo

Interventions

Oral semaglutide DRUG

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)

Oral Semaglutide

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to read and speak Danish
• 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

You may not qualify if:

• Diabetes or renal impairment
• Medical history of significant eye disease (including ocular trauma) other than glaucoma
• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Miriam Kolko, MD, PhD

CONTACT

+45 29807667; miriamk@sund.ku.dk

Anna-Sophie Thein

CONTACT

anna-sophie.thein@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Translational Eye Research, Chief Physician.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)