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

Launched by MEDIBEACON · Jul 1, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new dye called MB-102, which is being tested to see how safe it is and how well it works for imaging the blood vessels in the eye, compared to a standard dye called fluorescein sodium. This imaging process, known as fluorescent angiography, helps doctors diagnose and monitor various eye conditions like diabetic retinopathy and macular degeneration. The study aims to include adults aged 18 and older, including both men and women, but there are some important eligibility criteria. For example, women who are pregnant or planning to become pregnant can't participate, and participants should not have certain health issues or be involved in other clinical trials that might affect the study's results.

If you choose to participate, you'll need to sign a consent form and be willing to follow the study's requirements. The trial is not yet recruiting participants, but when it starts, those eligible will have some tests to ensure they can tolerate the imaging process. It's essential to understand that this study is focused on safety and the quality of images produced by MB-102, which could lead to better ways of diagnosing and monitoring eye diseases in the future.

Gender

ALL

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 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