Semaglutide for Glaucoma

Inclusion criteria

• {"criterion_text":"- Ability to read and speak Danish\n- 45 years or older at the time of inclusion\n- Visual acuity equal to or above 0.5 in the study eye\n- Diagnosis of primary open-angle glaucoma with mean deviation (MD) ≤ 16 dB with repeatable and reliable (false positive less than 15 %) visual field loss measured by standard automated perimetry on at least one eye\n- Receiving intraocular pressure (IOP) lowering glaucoma treatment\n- Nerve fiber layer defects identified by optical coherence tomography (OCT)"}

Exclusion criteria

• {"criterion_text":"- Diabetes or renal impairment\n- Previous history of pancreatitis\n- BMI < 18.5\n- Subjects receiving treatment with: Dipeptidyl peptidase–4 inhibitors, Other GLP-1RAs, Insulin, Insulin analogues, Sulfonylurea, Systemic corticosteroids, or Immunosuppressants\n- Medical history of significant eye disease (including ocular trauma) other than glaucoma\n- Ocular inflammation/infection within three months from inclusion\n- Intraocular surgery 3 months before inclusion\n- Smoker at the time of inclusion\n- Pregnant or breast-feeding\n- Females of childbearing potential who are not using adequate contraceptive\n- Subjects allergic to drug ingredients administered during the trial\n- Subjects with untreated severe systemic disease or malignancies"}

Primary endpoints

• {"endpoint_text":"- Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6.","definition_or_measurement_approach":"Assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6."}

Secondary endpoints

• {"endpoint_text":"- Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 3.","definition_or_measurement_approach":"Assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 3."}
• {"endpoint_text":"- Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.","definition_or_measurement_approach":"Assessed using the Pelli-Robson chart contrast sensitivity test."}
• {"endpoint_text":"- Health-related quality of life (HRQoL) assessed using two standardized validated questionnaires administered in Danish; the European Quality of life – 5 Dimensions – 3 Levels (EQ-5D-3L) questionnaire and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).","definition_or_measurement_approach":"Assessed using EQ-5D-3L and NEI VFQ-25 questionnaires administered in Danish."}
• {"endpoint_text":"- Safety and tolerance of oral semaglutide treatment in patients with glaucoma assessed by incidence of treatment emergent adverse events (TEAEs) and changes in safety-related blood analysis.","definition_or_measurement_approach":"Assessed by incidence of TEAEs and changes in safety-related blood analysis."}

Denmark

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

15-11-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

126

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}