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Dye

MB-102 Dye for Retinal Disorders

Phase < 1
Waitlist Available
Research Sponsored by MediBeacon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males must be willing to practice abstinence or utilize adequate contraception from MB-102 dosing day to at least 7 days post dose
Age > 18 years - male or female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of study enrollment until the end of adverse event collection, up to 24 days
Awards & highlights

Study Summary

This trial is testing if a new dye is safe and produces clear images compared to the current standard dye used in a diagnostic test for retinal problems.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares a new dye called MB-102 against a standard dye, fluorescein sodium, in producing eye images using different cameras. The goal is to assess MB-102's safety and the quality of images it provides for diagnosing and monitoring retinal diseases.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from known dyes like fluorescein sodium such as itching or hives. Severe reactions could involve anaphylaxis but are rare. Participants' tolerance will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control or abstain from sex for 7 days after my last dose.
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I am older than 18 years.
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I currently have a disease affecting the blood vessels in my eyes.
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I am not pregnant and will use birth control during the trial if I can have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of study enrollment until the end of adverse event collection, up to 24 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of study enrollment until the end of adverse event collection, up to 24 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
Secondary outcome measures
Number of participants with adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adult participants with normal or diseased eyesExperimental Treatment4 Interventions
500 mg dose of intravenous fluorescein sodium followed by ocular angiography; after a minimum of 3 days, participants will receive a single intravenous dose of MB-102 at 4 μmol/kg followed by ocular angiography

Find a Location

Who is running the clinical trial?

MediBeaconLead Sponsor
8 Previous Clinical Trials
891 Total Patients Enrolled
Richard B Dorshow, PhDStudy DirectorMediBeacon
4 Previous Clinical Trials
518 Total Patients Enrolled

Media Library

Retinal Disorders Clinical Trial 2023: MB-102 Highlights & Side Effects. Trial Name: NCT04008121 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for participation in this research endeavor?

"According to clinicaltrials.gov, this medical study is not currently enrolling patients although it was initially launched on October 1st 2022 and had its most recent update occur on June 9th 2022. However, there are still 283 other trials that are actively searching for volunteers."

Answered by AI

What past experiments have occurred with the combination of MB-102 and Zeiss FF450 fundus camera?

"Currently, there are 7 active clinical trials researching MB-102 and Zeiss FF450 fundus camera with 1 trial in its final phase. Of these studies, the majority of them are taking place in Aurora Colorado - although 222 locations across the globe have also opened their doors to participants."

Answered by AI

In what clinical setting is the MB-102 and Zeiss FF450 fundus camera applied?

"MB-102 and Zeiss FF450 fundus camera are oftentimes utilized when performing peritoneal dialysis therapy. Additionally, these medical tools can be beneficial for dealing with lymphocyte count measurement, genus pneumocystis, and pneumocystis jirovecii pneumonia."

Answered by AI

How many participants is this trial currently enrolling?

"Unfortunately, this trial is not currently accepting new participants; it was first posted on October 1st 2022 and the most recent update occurred June 9th 2022. Fortunately, there are 276 medical studies actively seeking those with diabetic retinopathy as well as 7 trials that require volunteers to use Zeiss FF450 fundus camera systems in conjunction with MB-102 therapy."

Answered by AI

Who else is applying?

What state do they live in?
New York
Georgia
Florida
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
~7 spots leftby Jul 2024