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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
Diagnosed with type 2 diabetes mellitus.
No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
Pivotal Trial

FOCUS 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.Check my eligibility
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.See study design
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.

FOCUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I have not had pan-retinal laser treatment.
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I have not had laser treatment for my entire retina.
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My eyes are healthy except for diabetes-related issues.
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Both of my eyes have a certain level of diabetic retinopathy.
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I have not had pan-retinal laser treatment.
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I haven't had eye treatments for diabetes-related conditions in the last 6 months.
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I have been diagnosed with type 2 diabetes.
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I am 18 years old or older.
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I don't expect to need eye treatment for diabetes-related conditions soon.
Select...
I don't expect to need eye treatment for diabetes-related conditions soon.

FOCUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Secondary outcome measures
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.

FOCUS 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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,493 Previous Clinical Trials
2,380,866 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
101,754 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: Semaglutide, Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Semaglutide's primary therapeutic purpose?

"Semaglutide is often prescribed to patients struggling with chronic weight management. However, it has also been known to help those who are on a calorie-restricted diet or have other conditions that are related to their weight."

Answered by AI

Is there room for more individuals in this clinical trial?

"Indeed, according to the clinicaltrials.gov website, this study is recruiting patients at this time. This specific trial was posted on 5/8/2019 and updated as recently as 8/10/2022. The goal is to enroll 1500 individuals across 50 different locations."

Answered by AI

What makes this research unique in comparison to other projects?

"Novo Nordisk A/S first sponsored a clinical trial for semaglutide in 2018. After the completion of the initial trial, which included 1387 participants, Semaglutide received its Phase 4 drug approval. Currently, there are 59 live trials for Semaglutide underway across 747 cities and 55 countries."

Answered by AI

What is the projected total of people signed up for this research project?

"The clinical trial is currently ongoing and actively recruiting participants, according to the listing on clinicaltrials.gov. This data was last edited on 8/10/2022, and the study originally posted on 5/8/2019. They are looking for 1500 people total from 50 different locations."

Answered by AI

If this isn't the first time Semaglutide has been under investigation, could you please tell us where else it has been studied?

"There are currently 59 ongoing studies regarding Semaglutide. Most of these are Phase 3 trials, with 27 taking place in Loma Linda, California. However, there 3838 total locations where Semaglutide clinical trials are being conducted."

Answered by AI

Semaglutide has been known to cause what serious adverse effects?

"There is some evidence of efficacy and several rounds of data supporting safety, giving Semaglutide a score of 3 on our team's 1-to-3 scale."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Other
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
1
0

What questions have other patients asked about this trial?

is there any pay? How long are screening visits? How long does the trial/Study last?
PatientReceived 1 prior treatment
What is the commitment and compensation? I do have to wear corrective lenses so am I still eligible?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Try something new. I have type 2 diabes. Qualifications match my profile. I am interested in helping people.
PatientReceived 1 prior treatment
I am having trouble stabilizing my.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
~544 spots leftby Dec 2026