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

Last updated: December 2, 2025
Sponsor: MediBeacon
Overall Status: Active - Recruiting

Phase

1

Condition

Retina

Vision Loss

Diabetic Retinopathy

Treatment

MB-102 and commercially available optical angiography imaging system

Fluorescein sodium and Zeiss FF450 fundus camera

Fluorescein sodium and commercially available optical angiography imaging system

Clinical Study ID

NCT04008121
MB-200-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years - male or female
  1. Eligible female non-pregnant participants who are either not of child-bearingpotential or willing to utilize adequate contraception during the trial

  2. Males must be willing to practice abstinence or utilize adequate contraceptionfrom 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

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 adequatecontraception

  • Participation in another interventional trial within 30 days of treatment orconcurrently enrolled in any other medical research study which could impact theresults 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 fluoresceinsodium or other related products (intolerance to a drug is not considered a drugallergy).

  • Prior history of seizures

  • Current visually significant cataracts or other ophthalmic conditions that wouldlimit appropriate collection of fundus photographs

  • Site personnel immediately associated with the study or their immediate familymembers

  • Unable to tolerate ophthalmologic imaging

  • Any characteristics which, in the opinion of the investigator, makes the participanta poor candidate for participation in the clinical trial (e.g. unstable medicalcondition including cardiovascular disease, or other conditions consideredclinically significant or unstable by the Principal Investigator)

  • Prior enrollment and dosing in this study

Study Design

Total Participants: 10
Treatment Group(s): 4
Primary Treatment: MB-102 and commercially available optical angiography imaging system
Phase: 1
Study Start date:
November 06, 2025
Estimated Completion Date:
May 31, 2026

Study Description

This will be a single-dose study, in normal participants and in those with current retinal pathology, investigating feasibility of the investigational dye, MB-102, for use in fluorescent angiography compared to fluorescein sodium. Safety and tolerability of MB-102 will also be evaluated. Control dye fluorescein sodium will be administered intravenously a minimum of 3 days prior to MB-102 dosing. After IV administration of dyes, images will be acquired of both eyes with a Zeiss fundus camera (and for some participants additional fundus photography will be performed with clinically-approved ocular angiography imaging systems) by a trained ophthalmic photographer. Participants will return for a follow-up visit after MB-102 dosing for further physical examination, clinical laboratory tests, and reporting of any adverse events. Photographs will be examined for quality as well as the utility of the angiography in evaluating disease diagnosis and progression.

Connect with a study center

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • University of Michigan Kellogg Eye Center

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Active - Recruiting

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