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Runcaciguat for Diabetic Retinopathy (NEON-NPDR Trial)
NEON-NPDR Trial Summary
This trial is testing a new drug to see if it's safe and effective in treating diabetic retinopathy, by looking at changes in the retina over time. The drug will be given for 24 weeks, and then they'll check to see if there have been any improvements.
NEON-NPDR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNEON-NPDR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NEON-NPDR Trial Design
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Who is running the clinical trial?
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- I have had specific laser treatments near the center of my retina or all over my retina in the study eye.My liver tests are high or I have fluid in my abdomen.My kidney function is significantly reduced.I have had a steroid injection in my eye.I have received treatments targeting blood vessel growth in my eye.I have or had swelling in the central part of my retina.My eye condition due to diabetes is moderately severe to severe.Your vision in the study eye is 20/40 or better on a standard eye chart.Your blood pressure is too low, with a systolic (top number) less than 100 or a diastolic (bottom number) less than 60.I haven't used nitrates, NO donors, or PDE5 inhibitors recently.I have diabetes.I have abnormal blood vessel growth in my eye.
- Group 1: Runcaciguat (BAY1101042)
- Group 2: Placebo
- 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
Are there many locations where this research project is taking place across North America?
"Currently, this clinical trial is operational in 14 locations. If you are considering participating in the study, please note that Poway, Redlands and Sacramento are some of the cities where sites are based. There may be a location close to you which would minimize travel requirements."
Are medical professionals still screening people for this study?
"This trial is still seeking patients, as evidenced by the clinicaltrials.gov listing which was published on 3/17/2021 and last edited on 10/20/2022."
Are there other available research papers on Runcaciguat (BAY1101042)?
"Currently, there is only one active study for the drug Runcaciguat (BAY1101042), and it has not yet reached Phase 3. That said, this research is being conducted in many locations - 97 total - with a large presence in London and Bayern."
How many patients are being given this treatment?
"98 patients that meet the study's requirements are necessary to complete the research. Bayer, the sponsor of the trial, will be managing the study from various locations; two examples include Retina Consultants San Diego in Poway, California and Retina Consultants of Southern California in Redlands."
Has this type of treatment been done before?
"Runcaciguat (BAY1101042) has been studied since 2021. The first study, sponsored by Bayer, was completed in that year and involved 98 patients. As a result of the findings in that initial research project, Runcaciguat (BAY1101042) progressed to Phase 2 drug approval stage. Presently, there is a single live trial for Runcaciguat (BAY1101042), once again being sponsored by Bayer."
Has Runcaciguat (BAY1101042) received FDA approval?
"Runcaciguat (BAY1101042) is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, there is no data indicating that the medication is effective."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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