No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
10 (estimated)
Sponsor
MediBeacon · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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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