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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
MediBeacon
Study ID
NCT04008121
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fluorescein sodium and Zeiss FF450 fundus camera — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    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

Study Details

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.

Key Dates

Start date
Nov 6, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Kellogg Eye CenterAnn ArborMichigan48105
Julie M Rosenthal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Diabetic retinopathyAge-related macular degeneration
By specialty
OphthalmologyRetina
By research site
University of Michigan Kellogg Eye Center· Ann Arbor, MI

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