Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Start Date
11/6/2025
Completion Date
12/1/2026
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Fluorescein sodium and Zeiss FF450 fundus camera
MB-102 and Zeiss FF450 fundus camera
Fluorescein sodium and commercially available optical angiography imaging system
MB-102 and commercially available optical angiography imaging system
Conditions
Locations
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan 48105
United States