A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)

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A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)

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Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Male or female, age greater than or equal to 18 years
  2. Diagnosed with type 2 diabetes mellitus.
  3. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
  4. Eye inclusion criteria (both eyes must meet all criteria):
  5. Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography
  6. No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within six months
  7. No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months
  8. Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
  9. No previous treatment with pan-retinal laser photocoagulation
  10. No substantial non-diabetic ocular condition
  11. No substantial media opacities that would preclude successful imaging
Exclusion Criteria
  1. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days
  2. Planned coronary, carotid or peripheral artery revascularisation
  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/min/1.73 m^2
  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. 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. Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor.
  9. Receipt of any investigational medicinal product within 30 days
  10. Previous participation in this trial. Participation is defined as randomisation
  11. Known or suspected hypersensitivity to trial products or related products
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