Actively Recruiting
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Led by MediBeacon · Updated on 2026-02-04
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and image quality of a new dye called MB-102 compared to the standard dye fluorescein sodium. This study involves both healthy adults and those with retinal diseases such as retinopathy, retinal vein occlusion, diabetic retinopathy, and macular degeneration. The purpose is to see if MB-102 is feasible and safe for use in fluorescent angiography to help diagnose and monitor these eye conditions. Participants will receive two intravenous dye injections during the study. First, they will get the control dye fluorescein sodium, followed by eye imaging using a Zeiss fundus camera and, for some, other approved ocular angiography systems. At least three days later, they will receive a single dose of MB-102, followed by similar imaging procedures. This single-dose design allows comparison of the two dyes in the same participants. During the study, participants will have eye photographs taken to assess image quality and usefulness for disease evaluation. They will return for follow-up visits including physical exams, lab tests, and monitoring for any side effects or adverse events. The main outcome measured is whether MB-102 imaging is feasible compared to fluorescein sodium, with safety monitored up to 24 days after enrollment. Participation lasts up to about two weeks after dye administration.
CONDITIONS
Brief Title
Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years, male or female
- Eligible females must be non-pregnant and either not of child-bearing potential or willing to use contraception during the trial
- Males must be willing to abstain or use contraception from MB-102 dosing day to at least 7 days after
- Willingness to comply with study requirements
- Signed informed consent form
- At least 5 participants will have current retinal or choroidal vascular diseases
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy women, or women of childbearing potential unwilling to use contraception
- Participation in another interventional trial within 30 days or concurrent enrollment in other medical research affecting results
- History of drug or alcohol abuse within the past year
- History of severe allergic reactions or anaphylactoid reactions to any allergen including MB-102 or fluorescein sodium
- Prior history of seizures
- Current visually significant cataracts or ophthalmic conditions limiting fundus photography
- Site personnel or immediate family members involved in the study
- Unable to tolerate ophthalmologic imaging
- Any unstable or clinically significant medical condition as judged by the investigator
- Prior enrollment and dosing in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of fluorescein sodium followed by ocular angiography imaging of both eyes using a Zeiss fundus camera. A subset of participants will also have additional imaging with clinically-approved ocular angiography systems.
1 visit (in-person)
Duration - 1 day
At least 3 days after fluorescein sodium imaging, participants receive a single intravenous dose of MB-102 followed by ocular angiography imaging of both eyes using a Zeiss fundus camera. A subset of participants will also have additional imaging with clinically-approved ocular angiography systems.
1 visit (in-person)
Duration - Up to 2 weeks after MB-102 dosing
Participants return for a follow-up visit after MB-102 dosing for physical examination, clinical laboratory tests, and reporting of any adverse events.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
R
Richard B Dorshow, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here