Recruiting
Early Phase 1

MB-102

Sponsor:

MediBeacon

Code:

NCT04008121

Conditions

Retinopathy

Retinal Vein Occlusion

Diabetic Retinopathy

Macular Degeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Retinopathy

Retinal Vein Occlusion

Diabetic Retinopathy

Macular Degeneration

Study ID

NCT04008121

Start date

Nov 6, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Adult participants with normal or diseased eyes

500 mg dose of intravenous fluorescein sodium followed by ocular angiography; after a minimum of 3 days, participants will receive a single intravenous dose of MB-102 at 4 μmol/kg followed by ocular angiography

Interventions

Fluorescein sodium and Zeiss FF450 fundus camera

Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

MB-102 and Zeiss FF450 fundus camera

MB-102 administered 3 days after fluorescein sodium as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants

Fluorescein sodium and commercially available optical angiography imaging system

Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

MB-102 and commercially available optical angiography imaging system

Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants

Primary outcome measure

  • Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye [ Time Frame: From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48105

Principal Investigator:

Julie M Rosenthal, MD

More Information

Sponsor

MediBeacon

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Fluorescein angiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MediBeacon on 2026-02-04.