MB-102 Dye for Retinal Disorders

Overseen By Richard B Dorshow, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: MediBeacon

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

Trial Summary

What is the purpose of this trial?

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 healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.

Research Team

Richard B Dorshow, PhD

Principal Investigator

MediBeacon

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+