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

NCT04008121 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-04

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

Sponsors & Collaborators

  • MediBeacon

    lead INDUSTRY

Principal Investigators

  • Richard B Dorshow, PhD · MediBeacon

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04008121 on ClinicalTrials.gov