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Semaglutide for Diabetic Eye Disease (FOCUS Trial)
FOCUS Trial Summary
This trial will compare the effect of semaglutide vs placebo on diabetic eye disease, in people with type 2 diabetes.
FOCUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFOCUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848FOCUS Trial Design
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Who is running the clinical trial?
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- I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.I haven't had eye treatments for diabetes-related conditions in the last 6 months.Your eyes cannot have any major cloudiness that would make it hard to take pictures of them.I have not had laser treatment for my entire retina.Your vision with glasses or contacts is better than or equal to reading 30 letters on an eye chart using a specific test.Your HbA1c level is between 7.0% and 10.0%.I am 18 years old or older.You don't have any eye conditions, other than diabetes, that might affect how diabetic retinopathy or diabetic macular edema changes during the trial, according to the eye doctor.My eyes are healthy except for diabetes-related issues.Both of my eyes have a certain level of diabetic retinopathy.I don't expect to need eye treatment for diabetes-related conditions soon.You have a certain level of diabetic retinopathy, as confirmed by a special eye test.Your eyes cannot have anything blocking the camera's view.Your HbA1c level is between 7.0% and 10.0%.My kidney function is low, with an eGFR under 30.I have been diagnosed with type 2 diabetes.I have not had pan-retinal laser treatment.Your vision with glasses or contacts is better than a certain level when tested using a specific vision chart.I have not had a heart attack, stroke, or severe chest pain in the last 60 days.My eyes are healthy except for diabetes-related issues.I or my close family member have a history of a specific thyroid cancer or genetic condition.I haven't had cancer, except for some skin cancers or early-stage cancers, in the last 5 years.Your eyes cannot have any major problems that would make it hard to take pictures of them.I am 18 years old or older.My heart condition severely limits my physical activity.I have not had pan-retinal laser treatment.I haven't had eye treatments for diabetes-related conditions in the last 6 months.I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.I have been diagnosed with type 2 diabetes.Your vision with glasses or contacts is better than a certain level on a special eye test.I am currently taking GLP-1 receptor agonists or DPP-4 inhibitors.I don't expect to need eye treatment for diabetes-related conditions soon.I don't expect to need eye treatment for diabetes-related conditions soon.
- Group 1: Semaglutide
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Novo Nordisk Investigational Site: < 24 hours
Average response time
- < 2 Days
Typically responds via
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