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Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
RecruitingEarly phase 1Healthy volunteers welcome
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Age \> 18 years - male or female 1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial 2. Males must be willing to practice abstinence or utilize adequate contraception from MB-102 dosing day to at least 7 days post dose * Participants willing to comply with study requirements * Participants who have signed an informed consent form At least 5 participants will have a current history of retinal or choroidal vascular diseases. Exclusion Criteria: * 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
About the study
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.
What is being tested
- Fluorescein sodium and Zeiss FF450 fundus camera (combination product)
- MB-102 and Zeiss FF450 fundus camera (combination product)
- Fluorescein sodium and commercially available optical angiography imaging system (combination product)
- MB-102 and commercially available optical angiography imaging system (combination product)
Sponsor: MediBeacon · Participants: 10 · Started: Nov 6, 2025
Contact the study team
- Richard B Dorshow, PhD · Phone: 314-735-0967
Official record on ClinicalTrials.gov — NCT04008121
Locations in the U.S.
| Michigan | University of Michigan Kellogg Eye Center, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.