RecruitingEarly Phase 1NCT04008121

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

A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium


Sponsor

MediBeacon

Enrollment

10 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new eye imaging dye called MB-102 to the standard dye fluorescein sodium, which is commonly used in a procedure called ocular angiography to visualize blood vessels in the eye. Doctors use these dyes to diagnose and monitor conditions like macular degeneration and diabetic eye disease. The study is testing whether MB-102 is a safe and effective alternative. Fluorescein sodium has been used for decades but can sometimes cause side effects. MB-102 is a newer compound that researchers believe may work similarly with a potentially improved safety profile. This study compares image quality and safety between the two dyes in adult patients. **You may be eligible if...** - You are 18 years of age or older - You are willing to comply with study requirements and have signed informed consent - If female, you are either not of childbearing potential or are using adequate contraception - If male, you are willing to use contraception or abstain for 7 days after the dose **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant - You have had a prior allergic reaction or anaphylaxis to MB-102, fluorescein, or similar substances - You have a history of seizures - You have participated in another interventional trial within 30 days - You have a history of drug or alcohol abuse within the past year - You have significant cataracts or other eye conditions that would interfere with photography **Talk to your doctor** about your eye health history, any allergy history, and whether you are a good candidate for this imaging procedure comparison.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFluorescein 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

COMBINATION_PRODUCTMB-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

COMBINATION_PRODUCTFluorescein 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

COMBINATION_PRODUCTMB-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


Locations(1)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

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NCT04008121


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