NCT04008121RecruitingEarly phase 1
Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 May 2019
- Start date
- 6 Nov 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- MediBeacon
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT04008121
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 6 Nov 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of seizures
- Prior enrollment and dosing in this study
Other illness
- History of drug or alcohol abuse within the past year
- Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs
- 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)
Lab values
- 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).
Other
- 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
- Site personnel immediately associated with the study or their immediate family members
- Unable to tolerate ophthalmologic imaging
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Kellogg Eye Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.