MB-102 for Eye Imaging in Retinal Diseases

This study is testing a new imaging dye called MB-102. It's being compared to a standard dye, fluorescein sodium, which is currently used to take pictures of the back of your eye. The goal is to see if MB-102 is safe and produces clear images for diagnosing and monitoring eye conditions like retinopathy, retinal vein occlusion, diabetic retinopathy, and macular degeneration. You could be eligible if you are an adult (18 years or older) and meet certain contraception requirements. The study will look at whether MB-102 images are as good as or better than those from fluorescein sodium. The current status of this study is unclear, and it plans to enroll 10 participants.

Study design
This is an interventional study comparing MB-102 to fluorescein sodium in a small group of 10 participants.
What's involved
You will receive both fluorescein sodium and MB-102 injections, with eye imaging after each. There will be a follow-up visit after the MB-102 dose for exams and to report any side effects.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks.

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NCT04008121

Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
MediBeacon
~10 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Fluorescein sodium and Zeiss FF450 fundus cameraMB-102 and Zeiss FF450 fundus cameraFluorescein sodium and commercially available optical angiography imaging systemMB-102 and commercially available optical angiography imaging system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
Measured over From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks
Retinopathy
Retinal Vein Occlusion
Diabetic Retinopathy
Macular Degeneration
1 sites across 1 states
Michigan1
  • Richard B Dorshow, PhD · STUDY_DIRECTOR · MediBeacon

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 18 years - male or female
Participants willing to comply with study requirements
Participants who have signed an informed consent form

Exclusion

Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to utilize adequate contraception
Participation in another interventional trial within 30 days of treatment or concurrently enrolled in any other medical research study which could impact the results of the study
History of drug or alcohol abuse within the past year
History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and fluorescein sodium or other related products (intolerance to a drug is not considered a drug allergy).
Prior history of seizures
Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs
Site personnel immediately associated with the study or their immediate family members
Unable to tolerate ophthalmologic imaging
Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial (e.g. unstable medical condition including cardiovascular disease, or other conditions considered clinically significant or unstable by the Principal Investigator)
Prior enrollment and dosing in this study
  • Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dyeFrom the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks

    Ocular angiography will be performed using a commercially available, FDA-approved clinical Zeiss FF450 fundus camera. Images will be taken of both eyes, acquired by a trained ophthalmic photographer. In at least 2 participants, imaging will also be conducted using 2 different additional clinically-approved ocular angiography imaging systems.