Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGEarly Phase 1INTERVENTIONAL

Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form At least 5 participants will have a current history of retinal or choroidal vascular diseases. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

COMBINATION_PRODUCT

Fluorescein sodium and Zeiss FF450 fundus camera

Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

COMBINATION_PRODUCT

MB-102 and Zeiss FF450 fundus camera

MB-102 administered 3 days after fluorescein sodium as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

COMBINATION_PRODUCT

Fluorescein sodium and commercially available optical angiography imaging system

Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

COMBINATION_PRODUCT

MB-102 and commercially available optical angiography imaging system

Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

Locations (1)

University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States