A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Michigan
University of Michigan Kellogg Eye Center
RECRUITING
Ann Arbor
Contact Information
Primary
Richard B Dorshow, PhD
rbdorshow@medibeacon.com
314-735-0967
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2026-05
Participants
Target number of participants: 10
Treatments
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
Sponsors
Leads: MediBeacon

This content was sourced from clinicaltrials.gov