Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediBeacon
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years - male or female
Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Fluorescein sodium and Zeiss FF450 fundus camera
Combination productFluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants
MB-102 and Zeiss FF450 fundus camera
Combination productMB-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
Fluorescein sodium and commercially available optical angiography imaging system
Combination productFollowing 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
MB-102 and commercially available optical angiography imaging system
Combination productFollowing 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
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Adult participants with normal or diseased eyesExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
Ocular angiography will be performed using a commercially available, FDA-approved clinical Zeiss FF450 fundus camera. Images will be taken of both eyes, acquired by a trained ophthalmic photographer. In at least 2 participants, imaging will also be conducted using 2 different additional clinically-approved ocular angiography imaging systems.
Time frame
From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeksSecondary outcomes
1
Number of participants with adverse events
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, temporally associated with the use of a medicinal product, whether or not related to the investigational drug or the reference medication. Adverse events will be collected from the time a participant is considered enrolled (after consent is signed) through the follow-up visit. Participants who fail screening will not have AEs collected.
Time frame
From the time of study enrollment until the end of adverse event collection, up to 24 days Source ClinicalTrials.gov