Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Recruiting now · Early Phase 1
Conditions studied: Retinopathy, Retinal Vein Occlusion, Diabetic Retinopathy, Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT04008121
- Run by
- MediBeacon
- People needed
- 10
- Starts
- 2025-11-06
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age > 18 years - male or female
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial
- 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.
You may not qualify if…
- 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
Where it is running
- University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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