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

Launched by GLOSTRUP UNIVERSITY HOSPITAL, COPENHAGEN · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called oral semaglutide can help treat open-angle glaucoma, a condition that affects vision. The main goal is to see if this medicine can safely improve how well the inner part of the eye works, which will be measured using a special eye test. Participants in the study will take either oral semaglutide or a placebo (a harmless pill that looks like the real medicine but has no active ingredients) every day for six months. They will also visit the clinic five times during this period for tests and interviews.

To be eligible for this trial, participants need to be at least 45 years old, able to read and speak Danish, and have a specific level of vision and eye health related to glaucoma. They must also be currently receiving treatment to lower eye pressure. However, people with certain conditions, like diabetes or severe eye disease, as well as pregnant or breastfeeding women, cannot participate. This study is still recruiting participants, so if you or a family member are interested, it may be a good opportunity to help advance our understanding of glaucoma treatment.

Gender

ALL

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