BridgeMD
Compares treatment options for Retinopathy
Official title Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
ClinicalTrials.gov ID: NCT04008121
What this study is testing
What is Fluorescein sodium and Zeiss FF450 fundus camera?
Fluorescein sodium and Zeiss FF450 fundus camera is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Participants who have signed an informed consent form At least 5 participants will have a current history of retinal or choroidal vascular diseases.
You likely can't join if
- Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to utilize...
- Participation in another treatment trial within 30 days of treatment or concurrently enrolled in any other medical research study which could impact...
- 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...
- Prior history of seizures
- Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs
See the full eligibility criteria
- 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
- Participants who have signed an informed consent form At least 5 participants will have a current history of retinal or choroidal vascular diseases.
- 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 treatment 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...
- 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...
- Prior enrollment and dosing in this study
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.