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KSI-301 for Diabetic Macular Edema (GLIMMER Trial)
GLIMMER Trial Summary
This trial will compare an experimental drug to aflibercept to see if it is more effective, lasts longer, and is safer in people who have not been treated for DME before.
- Diabetic Macular Edema
GLIMMER 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 2023 Phase 3 trial • 557 Patients • NCT04964089GLIMMER Trial Design
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- The letter score is between 78 and 25 (Snellen equivalent) in the Study Eye.There may be additional requirements you need to meet as outlined by the study guidelines.You have Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.You have recently been diagnosed with diabetic macular edema, which has caused vision loss and affects the center of your vision.You have swelling in the central part of your eye called macular edema, but it is caused by something other than diabetic macular edema (DME).You have received laser treatment in your study eye within the past 3 months.You have an eye condition other than the one being studied that is currently active.You have not received any previous treatments for DME in the eye being studied, like injections or laser therapy.Within the past 6 months, you have had a heart attack, stroke, or other serious heart-related problems.You have a central retinal thickness of 320 microns or more.You have recently been diagnosed with diabetic macular edema, a condition that causes vision loss and affects the center of your vision.You have an eye condition that could need medical or surgical treatment, or could affect your vision during the study.You have an eye infection or inflammation at the start of the study.
- Group 1: KSI-301 (Arm A)
- Group 2: Aflibercept (Arm B)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is KSI-301 harmful to human beings?
"Our team at Power estimates that KSI-301 is safe to use, as it has received a score of 3. This is because Phase 3 trials have shown some efficacy and multiple rounds of data support its safety."
In how many hospitals is this research being conducted?
"There are 54 different centres where this trial is taking place. If you want to enroll in the study, try and select a location near you from The Woodlands, Cleveland, Boca Raton or one of the other 51 sites to cut down on travel."
Are people still able to sign up for this clinical trial?
"Unfortunately, this particular trial is not currently looking for any more patients. According to the information on clinicaltrials.gov, the last date that this study was updated was June 2nd, 2022 and it originally posted on September 30th, 2020. There are, however, 170 other trials which are still recruiting individuals."
What are the primary indications for KSI-301?
"KSI-301 is an effective medical intervention for patients with wet age-related macular degeneration (wamd), macular edema, and diabetic macular edema (dme)."
How many people are allowed to enroll in this clinical trial?
"Presently, this study is not recruiting patients for participation. The clinical trial was initially posted on 9/30/2020 and was most recently updated on 6/2/2022. However, there are 119 trials actively looking for patients with edema and 51 studies for KSI-301 that are still recruiting participants."
Could you please provide a rundown of other research that has included KSI-301?
"KSI-301 was first studied in 2013 at the well-renowned Massachusetts General Hospital. As of now, a total of 251 clinical trials have completed. Out of these, 51 are currently recruiting patients with a large number hailing from The Woodlands, Ohio."
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