MB-102 versus fluorescein sodium for retinal angiography imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.