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Glucagon-like peptide-1 receptor agonist

Semaglutide for Diabetic Eye Disease (FOCUS Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Both eyes must meet the following criteria: Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
Diagnosed with type 2 diabetes mellitus.
Must not have
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effect of semaglutide vs placebo on diabetic eye disease, in people with type 2 diabetes.

Who is the study for?
Adults with type 2 diabetes and moderate diabetic eye disease, who haven't had certain eye treatments or conditions that could affect the study. They should have an HbA1c level between 7.0-10.0% and not be on any GLP-1 receptor agonists or DPP-4 inhibitors from randomisation.
What is being tested?
The trial is testing if semaglutide can help diabetic eye disease compared to a placebo over five years. Participants will inject either semaglutide or placebo once a week alongside their regular diabetes medication.
What are the potential side effects?
Semaglutide may cause digestive issues like nausea, vomiting, diarrhea, possible low blood sugar events, and rare but serious side effects such as pancreatitis or thyroid tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Both of my eyes have a certain level of diabetic retinopathy.
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I have been diagnosed with type 2 diabetes.
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I have not had pan-retinal laser treatment.
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.
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I don't expect to need eye treatment for diabetes-related conditions soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.
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My kidney function is low, with an eGFR under 30.
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I or my close family member have a history of a specific thyroid cancer or genetic condition.
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My heart condition severely limits my physical activity.
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I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.
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I am currently taking GLP-1 receptor agonists or DPP-4 inhibitors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Secondary study objectives
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.
Body Weight Changes
Change in glycosylated haemoglobin (HbA1c).
+18 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,552 Previous Clinical Trials
2,443,560 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
101,758 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03811561 — Phase 3
Type 2 Diabetes Research Study Groups: Placebo, Semaglutide
Type 2 Diabetes Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT03811561 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811561 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03811561 — Phase 3
~412 spots leftby Dec 2026
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