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

NCT04008121 · tracked via the Priya Life Science USA tracker

Sponsor

MediBeacon

Phase

Early Phase 1

Started

2025-11-06

Last updated

2026-02-04

Condition(s) studied

RetinopathyRetinal Vein OcclusionDiabetic RetinopathyMacular Degeneration

Investigational drug(s) / intervention(s)

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

Fluorescein sodium and Zeiss FF450 fundus camera: Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

MB-102 and Zeiss FF450 fundus camera: MB-102 administered 3 days after fluorescein sodium as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

Fluorescein sodium and commercially available optical angiography imaging system: Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

MB-102 and commercially available optical angiography imaging system: Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye — From 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.

Trial sites (1)

Facility	City	Region	Status
University of Michigan Kellogg Eye Center	Ann Arbor	Michigan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04008121 on ClinicalTrials.gov ↗ ← All trials in the USA