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NCT Number: NCT03811561

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

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CPQuali Pesquisa Clínica Ltda, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
  • Eye inclusion criteria (both eyes must meet all criteria):
  • Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
  • No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
  • No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
  • Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
  • No previous treatment with pan-retinal laser photocoagulation
  • 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
  • No substantial media opacities that would preclude successful imaging

Exclusion criteria

  • 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
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • 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
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
  • Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
  • Receipt of any investigational medicinal product within 30 days before screening
  • Previous participation in this trial. Participation is defined as randomisation
  • Known or suspected hypersensitivity to trial products or related products
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Treatment and study plan

semaglutide

Drug

Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Placebo (semaglutide)

Drug

Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Primary outcomes

  1. Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.

    Time frame: Year 5

    Percentage of subjects (yes/no).

Secondary outcomes

  1. Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.

    Time frame: Up to 5 years

    Measured in months.

  2. Change in visual acuity in the worse seeing eye.

    Time frame: Week 0, Year 5

    Measured in number of letters using the ETDRS protocol.

  3. Change in visual acuity in the better seeing eye.

    Time frame: Week 0, Year 5

    Measured in number of letters using the ETDRS protocol.

  4. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.

    Time frame: Week 0-Year 5

    Percentage of subjects (yes/no).

  5. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.

    Time frame: Week 0-Year 5

    Percentage of subjects (yes/no).

  6. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).

    Time frame: Week 0-Year 5

    Percentage of subjects (yes/no).

  7. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.

    Time frame: Week 0-Year 5

    Percentage of subjects (yes/no).

  8. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.

    Time frame: Week 0-Year 5

    Percentage of subjects (yes/no).

  9. Presence of at least 3 steps ETDRS subject level improvement.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  10. Presence of at least 2 steps ETDRS subject level progression.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  11. Presence of at least 2 steps ETDRS subject level improvement.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  12. Presence of persistent visual acuity up to 38 ETDRS letters in either eye.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  13. Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  14. Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  15. Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  16. Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  17. Presence of ciDME in either eye.

    Time frame: Year 5

    Percentage of subjects (yes/no).

  18. Change in glycosylated haemoglobin (HbA1c).

    Time frame: Week 0, Year 5

    Measured in %-points.

  19. Change in body weight.

    Time frame: Week 0, Year 5

    Measured in kg.

  20. Change in systolic and diastolic blood pressure.

    Time frame: Week 0, Year 5

    Measured in mmHg.

  21. Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.

    Time frame: Week 0, Year 5

    Measured in mmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: FOCUS

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2019
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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