A research study to look at how semaglutide compared to placebo affects diabetic eye disease in people with type 2 diabetes (FOCUS)
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2019/06/019817
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Male or female, age =18 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus = 10 years prior to the day of screening.
4. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
Eye inclusion criteria (both eyes must meet all criteria):
5. ETDRS level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by
central reading centre.
6. No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema twelve
months prior to the day of screening.
7. No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic
macular oedema within six months after randomisation.
8. Best-corrected visual acuity =30 letters using the ETDRS visual acuity protocol.
9. No previous treatment with pan-retinal laser photocoagulation
10. No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would
impact diabetic retinopathy or diabetic macular oedema progression during the trial.
11. No substantial media opacities that would preclude successful imaging.
Subjects are excluded from the trial if any of the following criteria apply:
1. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening.
2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
3. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
4. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of
eGFR less than 30 ml per min per 1.73 m2.
5. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
6. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
8. Current or previous (within 30 days before screening) treatment with any GLP-1 receptor agonist or DPP-4 inhibitor.
9. Receipt of any investigational medicinal product within 30 days before screening.
10. Previous participation in this trial. Participation is defined as randomisation.
11. Known or suspected hypersensitivity to trial products or related products.
12. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
Based on medical history using latest available and no more than 6 months old assessment. If not available in medical records a local laboratory measurement must be made available before randomisation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is presence of more than or equal to 3 steps ETDRS (Early Treatment Diabetic Retinopathy <br/ ><br>Study) subject level progression at year 5.Timepoint: 5 Years
- Secondary Outcome Measures
Name Time Method