MB-102 Dye for Retinal Disorders

Overseen By Richard B Dorshow, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: MediBeacon

Disqualifiers: Pregnancy, Drug abuse, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

10 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

I agree to use birth control or abstain from sex for 7 days after my last dose.

I am older than 18 years.

Participants willing to comply with study requirements

Exclusion Criteria

I have had seizures in the past.

You have had problems with drugs or alcohol in the past year.

You are unable to undergo eye exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

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

1 week

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

1 week

What Are the Treatments Tested in This Trial?

Interventions

• MB-102

Trial Overview

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.

How Is the Trial Designed?

Group I: Adult participants with normal or diseased eyes Experimental Treatment 4 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

Who Is Running the Clinical Trial?

MediBeacon

Lead Sponsor

Trials

9

Recruited

830+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32343181/

Effectiveness of MB-102, a novel fluorescent tracer agent ...

No significant difference was noted between the 2 dyes in any phase or phase interval, and slight improvement in image contrast was observed with MB-102 during ...

2.

avmajournals.avma.org

avmajournals.avma.org/view/journals/ajvr/81/5/ajvr.81.5.428.xml

Effectiveness of MB-102, a novel fluorescent tracer agent, for ...

Overall, use of MB-102 resulted in visualization and vascular details in both ophthalmologically normal and diseased eyes comparable to results ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/d5944597a875ee37/nct04008121-pilot-study-mb-102-ocular-angiography

Feasibility and Safety of MB-102 in Ocular Angiography as ...

The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) ...

4.

researchgate.net

researchgate.net/publication/283025104_Results_of_the_first-in-human_clinical_trial_for_MB-102_a_novel_fluorescent_tracer_agent_for_real-time_measurement_of_glomerular_filtration_rate

Results of the first-in-human clinical trial for MB-102, a ...

Objective: To evaluate the effectiveness of a novel fluorescence tracer agent, MB-102, for conducting ocular angiography in dogs. Animals ...

5.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0041555

Retinal Disorders (DBCOND0041555)

Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium ... DETECT and Retinal Outcomes in Hypertension, No drug ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04008121?tab=history&a=5

Record History | ver. 5: 2020-11-23 | NCT04008121

The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in ...

7.

withpower.com

withpower.com/trial/early-phase-1-retinal-diseases-2-2022-262b4

MB-102 Dye for Retinal Disorders · Info for Participants

The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) ...

8.

medibeacon.com

medibeacon.com/wp-content/uploads/2020/01/Canine_Ocular_Angiography_Poster_2019-1.pdf

MB-102: A NOVEL TRACER AGENT FOR CANINE ...

expected safety profile, MB-102 should allow an expansion in how ocular angiography may be employed to diagnose and monitor a variety of ophthalmic diseases.