Investigating oral semaglutide for treating open-angle glaucoma
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
PHASE4 · Glostrup University Hospital, Copenhagen · NCT06792422
This study is testing if a daily pill called semaglutide can help improve vision in people with open-angle glaucoma.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Glostrup University Hospital, Copenhagen (other) |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT06792422 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of oral semaglutide in improving inner retinal function in patients diagnosed with open-angle glaucoma. Participants will be randomly assigned to receive either oral semaglutide or a placebo daily for six months. The primary outcome will be measured through the photopic negative response of the electroretinogram, with participants visiting the clinic five times for assessments throughout the study period. The trial seeks to determine if semaglutide can provide a new treatment option for this condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older with a diagnosis of primary open-angle glaucoma and specific visual acuity and nerve fiber layer criteria.
Not a fit: Patients with diabetes, renal impairment, or significant eye diseases other than glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel treatment approach for patients with open-angle glaucoma, potentially improving their vision and quality of life.
How similar studies have performed: While the use of GLP-1 receptor agonists like semaglutide is novel in the context of glaucoma treatment, similar studies exploring alternative uses of diabetes medications have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glostrup Municipality
- Department of Ophthalmology, Rigshospitalet — Glostrup Municipality, Denmark (RECRUITING)
Study contacts
- Study coordinator: Miriam Kolko, MD, PhD
- Email: miriamk@sund.ku.dk
- Phone: +45 29807667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Open Angle Glaucoma, Open-Angle Glaucoma, Glaucoma, Semaglutide, Rybelsus, GLP-1RA, Photopic Negative Response, GLP-1