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โ† Trials
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Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

RecruitingEARLY Phase 1Ages 18 Years - anyAllMediBeacon
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
University of Michigan Kellogg Eye Center
Ann Arbor, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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