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

Sponsor
MediBeacon (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04008121
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Combination Product: Fluorescein sodium and Zeiss FF450 fundus camera
  • Combination Product: MB-102 and Zeiss FF450 fundus camera
  • Combination Product: Fluorescein sodium and commercially available optical angiography imaging system
  • Combination Product: MB-102 and commercially available optical angiography imaging system
Early Phase 1

Detailed Description

This will be a single-dose study, in normal participants and in those with current retinal pathology, investigating feasibility of the investigational dye, MB-102, for use in fluorescent angiography compared to fluorescein sodium. Safety and tolerability of MB-102 will also be evaluated. Control dye fluorescein sodium will be administered intravenously a minimum of 3 days prior to MB-102 dosing. After IV administration of dyes, images will be acquired of both eyes with a Zeiss fundus camera (and for some participants additional fundus photography will be performed with clinically-approved ocular angiography imaging systems) by a trained ophthalmic photographer. Participants will return for a follow-up visit after MB-102 dosing for further physical examination, clinical laboratory tests, and reporting of any adverse events. Photographs will be examined for quality as well as the utility of the angiography in evaluating disease diagnosis and progression.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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

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

Outcome Measures

Primary Outcome Measures

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

    Ocular angiography will be performed using a commercially available, FDA-approved clinical Zeiss FF450 fundus camera. Images will be taken of both eyes, acquired by a trained ophthalmic photographer. In at least 2 participants, imaging will also be conducted using 2 different additional clinically-approved ocular angiography imaging systems.

Secondary Outcome Measures

  1. Number of participants with adverse events [From the time of study enrollment until the end of adverse event collection, up to 24 days]

    An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, temporally associated with the use of a medicinal product, whether or not related to the investigational drug or the reference medication. Adverse events will be collected from the time a participant is considered enrolled (after consent is signed) through the follow-up visit. Participants who fail screening will not have AEs collected.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Michigan Kellogg Eye CenterAnn ArborMichiganUnited States48105

Sponsors and Collaborators

  • MediBeacon

Investigators

  • Study Director: Richard B Dorshow, PhD, MediBeacon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MediBeacon
ClinicalTrials.gov Identifier:
NCT04008121
Other Study ID Numbers:
  • MB-200-01
First Posted:
Jul 5, 2019
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by MediBeacon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021