MB-102 versus fluorescein sodium for retinal angiography imaging
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
This trial will test whether the new dye MB-102 produces safe, high-quality retinal angiography images in adults with healthy eyes or retinal vascular disease compared with standard fluorescein sodium.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediBeacon Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04008121 on ClinicalTrials.gov |
What this trial studies
This single-dose, early-phase study will enroll adults with normal eyes and adults with retinal or choroidal vascular disease to compare the safety and image quality of MB-102 versus fluorescein sodium during fluorescent angiography. Participants will receive fluorescein sodium intravenously at least three days before a single IV dose of MB-102, and retinal images will be captured with a Zeiss FF450 fundus camera and, for some participants, additional clinically approved angiography systems. Photographs will be reviewed for image quality and their usefulness in diagnosing or monitoring retinal vascular disease, and participants will return for follow-up exams, laboratory tests, and adverse event monitoring. Safety and tolerability of MB-102 will be recorded throughout the study.
Who should consider this trial
Good fit: Adults aged 18 and older who can give informed consent, tolerate intravenous dye injections, and either have current retinal/choroidal vascular disease or serve as healthy controls are appropriate candidates.
Not a fit: Pregnant or breastfeeding women, those unwilling or unable to use required contraception, people with recent drug or alcohol abuse, or those enrolled in conflicting interventional studies are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If MB-102 is safe and yields clearer images, it could provide a better or safer dye option for diagnosing and monitoring retinal vascular diseases.
How similar studies have performed: Fluorescein angiography is a well-established diagnostic method, but MB-102 is a novel investigational dye with limited prior human data, so its clinical value is relatively untested compared with standard dyes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years - male or female 1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial 2. 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. Exclusion Criteria: * 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Richard B Dorshow, PhD
- Email: rbdorshow@medibeacon.com
- Phone: 314-735-0967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.