MB-102 Dye for Retinal Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new dye called MB-102 to determine its safety and ability to provide clear images for diagnosing and monitoring eye diseases affecting blood vessels in the retina. Participants will first receive a standard dye, followed by the new dye, allowing researchers to compare the two. The trial seeks individuals with either healthy eyes or retinal issues, such as vascular diseases. It may suit those dealing with eye vessel problems or those with healthy eyes willing to help test this new imaging method. As an Early Phase 1 trial, participants will be among the first to receive this new dye, aiding researchers in understanding its safety and effectiveness in humans.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that MB-102 is likely to be safe for humans?
Research shows that MB-102, a new dye for eye imaging, is under evaluation to determine its safety compared to the standard dye, fluorescein sodium. Previous studies found no difference in how the body processes MB-102, even at higher doses up to 60 mg/kg, suggesting it is well-tolerated. However, as this trial is in an early stage, limited safety data in humans is available. This phase primarily checks for any unexpected side effects. So far, MB-102 has demonstrated a safety profile that meets expectations, indicating it appears safe for eye imaging.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about MB-102 for retinal disorders because it uses a new active ingredient that fluoresces under specific light conditions, potentially allowing for more precise imaging of the eye's blood vessels. Unlike traditional fluorescein angiography, which relies on sodium fluorescein, MB-102 may offer enhanced imaging clarity and safety. This novel approach could help doctors better diagnose and manage retinal conditions, making it a promising advancement in eye care.
What evidence suggests that MB-102 dye is effective for retinal disorders?
Research has shown that MB-102, a new dye for eye imaging, may help doctors see the retina more clearly. In studies, MB-102 produced images as good as, or better than, those made with the usual dye, fluorescein sodium. In this trial, participants will receive both dyes, with fluorescein sodium administered first, followed by MB-102 after a minimum of 3 days. This sequence may allow MB-102 to provide clearer pictures of the eye's blood vessels, which is crucial for diagnosing and tracking eye diseases. Although MB-102 is still under evaluation, early results suggest it could be a valuable tool for eye doctors.12678
Who Is on the Research Team?
Richard B Dorshow, PhD
Principal Investigator
MediBeacon
Are You a Good Fit for This Trial?
This trial is for adults over 18 with retinal or choroidal vascular diseases who can follow the study rules. Women must not be pregnant and willing to use birth control, and men must agree to contraception post-dose. It's not for those with conditions affecting eye imaging, in other trials, or unstable health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of fluorescein sodium followed by ocular angiography, and after a minimum of 3 days, a single intravenous dose of MB-102 followed by ocular angiography
Follow-up
Participants return for a follow-up visit after MB-102 dosing for further physical examination, clinical laboratory tests, and reporting of any adverse events
What Are the Treatments Tested in This Trial?
Interventions
- MB-102
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediBeacon
Lead Sponsor