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

NCT04008121 | Recruiting Early Phase 1 FDA Drug FDA Device

• 1 other identifier: MB-200-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinopathy; Retinal Vein Occlusion; Diabetic Retinopathy; Macular Degeneration

Keywords

Fluorescein angiography

Outcome Measures

Primary Outcomes (1)

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

  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.

  From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks

Secondary Outcomes (1)

• Number of participants with adverse events

  From the time of study enrollment until the end of adverse event collection, up to 24 days

Study Arms (1)

Adult participants with normal or diseased eyes

EXPERIMENTAL

500 mg dose of intravenous fluorescein sodium followed by ocular angiography; after a minimum of 3 days, participants will receive a single intravenous dose of MB-102 at 4 μmol/kg followed by ocular angiography

Combination Product: 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

Interventions

Fluorescein sodium and Zeiss FF450 fundus camera COMBINATION_PRODUCT

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

Adult participants with normal or diseased eyes

MB-102 and Zeiss FF450 fundus camera COMBINATION_PRODUCT

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

Adult participants with normal or diseased eyes

Fluorescein sodium and commercially available optical angiography imaging system COMBINATION_PRODUCT

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

Adult participants with normal or diseased eyes

MB-102 and commercially available optical angiography imaging system COMBINATION_PRODUCT

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

Adult participants with normal or diseased eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MediBeacon: lead

Study Sites (1)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Retinal Vein Occlusion; Diabetic Retinopathy; Macular Degeneration

Interventions

Fluorescein; relmapirazin

Condition Hierarchy (Ancestors)

Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Richard B Dorshow, PhD

  MediBeacon

  STUDY DIRECTOR

Central Study Contacts

Richard B Dorshow, PhD

CONTACT

314-735-0967; rbdorshow@medibeacon.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: July 5, 2019
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)