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RECRUITING
NCT04008121
EARLY_PHASE1

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

Sponsor: MediBeacon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-11-06

Completion Date

2026-12

Last Updated

2026-02-04

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

Locations (1)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States