Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06792422 (ABSALON) for Primary Open Angle Glaucoma (POAG), Open-Angle Glaucoma, Glaucoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma (ABSALON) Phase 4 126
Clinical Trial NCT06792422 (ABSALON) is designed to study Treatment for Primary Open Angle Glaucoma (POAG), Open-Angle Glaucoma, Glaucoma. It is a Phase 4 interventional study that is recruiting, having started on January 1, 2025, with plans to enroll 126 participants. Led by Glostrup University Hospital, Copenhagen, it is expected to complete by December 1, 2028. The latest data from ClinicalTrials.gov was last updated on January 24, 2025.
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 n...
Show MoreOfficial Title
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Conditions
Primary Open Angle Glaucoma (POAG)Open-Angle GlaucomaGlaucomaOther Study IDs
- ABSALON
- 97669
- NNF22OC0079544 (Other Grant/Funding Number) (The Novo Nordisk Foundation)
- 2024-518510-87-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2025-01
Last Update Posted
2025-01-24
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
126
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Glaucoma
Semaglutide
Rybelsus
Primary Open Angle Glaucoma
GLP-1RA
Photopic Negative Response
GLP-1
Semaglutide
Rybelsus
Primary Open Angle Glaucoma
GLP-1RA
Photopic Negative Response
GLP-1
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalOral Semaglutide Participants are given oral semaglutide once daily. | 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) |
Placebo ComparatorPlacebo Participants are given oral placebo once daily. | 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Photopic negative response of the electroretinogram after 3 months | Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram. | From baseline to month 3. |
Pelli-Robson chart contrast sensitivity test | Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test. | From baseline to month 6. |
Health-related quality of life (HRQoL) | 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. | From baseline to month 6. |
Health-related quality of life (HRQoL) | 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. | From baseline to month 6. |
Number of treatment-related adverse events as assessed by CTCAE v5.0 | 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. | From baseline to month 6. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
45 Years
Eligible Sexes
All
- 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
- 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
Glostrup University Hospital, CopenhagenStudy Responsible Party
Miriam Kolko, Principal Investigator, Professor in Translational Eye Research, Chief Physician., Rigshospitalet, Denmark
Study Central Contact
Contact: Miriam Kolko, MD, PhD, +45 29807667, [email protected]
Contact: Anna-Sophie Thein, [email protected]
1 Study Locations in 1 Countries
Department of Ophthalmology, Rigshospitalet, Glostrup Municipality, 2600, Denmark
Miriam Kolko, MD, PhD, Professor, Consultant, Contact, +45 29807667, [email protected]
Recruiting