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KSI-301 for Diabetic Macular Edema (GLEAM Trial)
GLEAM Trial Summary
This trial will compare an experimental drug, KSI-301, to aflibercept to see if it is more effective, has a longer lasting effect, and is safer in people with DME who have not yet had treatment.
- Diabetic Macular Edema
GLEAM 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 • 26 Patients • NCT03022292GLEAM Trial Design
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Who is running the clinical trial?
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- You had a heart attack, stroke, or other heart-related issue in the past 6 months.You have not received any previous treatments for DME in the eye being studied, such as medication injections or laser treatment.You have a pre-existing eye condition that could require medical or surgical treatment, or may affect your vision during the study.You have had Pan-retinal Photocoagulation (PRP) laser treatment in your study eye within the past 3 months.You have a CST of 320 microns or less as determined by the Reading Center.You have an eye condition that is not the same as the one being studied.You have an eye infection or inflammation at the start of the trial.You have recently been diagnosed with diabetic macular edema and have experienced vision loss and involvement of the center of your vision.You have been diagnosed with diabetic macular edema within the past 9 months and have experienced vision loss and involvement of the center of your vision.There may be additional requirements to participate in the study that are not listed here.You have Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.You have swelling in the macula of your eye, but it's not caused by diabetic macular edema (DME).
- 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
If there are several sites testing this new treatment, where are they located?
"Currently, 41 medical facilities are running this trial including The Retina Center of New jersey in Bloomfield, Foundation for Vision Research in Grand Rapids, and Vitreo Retinal Associates in Gainesville."
What are the conditions that KSI-301 is used to treat?
"KSI-301 is often used to mitigate the effects of wet age-related macular degeneration. Additionally, this medication can be helpful for patients suffering from macular edema, diabetic macular edema (dme), and regular macular degeneration."
Has KSI-301 undergone FDA approval?
"KSI-301 received a safety score of 3 from our analysts at Power. This is because KSI-301 is currently in Phase 3 trials, indicating that there is both efficacy data and multiple rounds of supportive safety data."
How many research participants are being asked to join this clinical trial?
"This study has already closed recruitment. The original posting date was September 30th 2020 and the most recent edit was on June 2nd, 2022. However, there are currently 119 trials actively recruiting participants with macular edema and 51 trials for KSI-301 that still need patients."
Has KSI-301 undergone any other medical testing before?
"KSI-301 was first studied in the year 2013 at Massachusetts General Hospital. Since then there are a total of 251 completed clinical trials. There are presently 51 live clinical trials, with many of these studies based out of Bloomfield, New jersey."
Are people still being recruited for this research project?
"According to the most recent update on clinicaltrials.gov, this particular trial is no longer recruiting patients. The trial was created on 9/30/2020 but has not been updated since 6/2/2022. There are, however, 170 other trials that are still looking for participants."
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