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
Qualifiers
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
Treatments tested in this trial
- 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
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov