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出境医 / 临床实验 / Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

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

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 disease Intervention/treatment Phase
Retinopathy Retinal Vein Occlusion Diabetic Retinopathy Macular Degeneration 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021
Arms and Interventions
Arm Intervention/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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts
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Contact: Richard B Dorshow, PhD 314-735-0967 rbdorshow@medibeacon.com

Locations
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United States, Michigan
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Principal Investigator: Yannis M Paulus, MD         
Sponsors and Collaborators
MediBeacon
Investigators
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Study Director: Richard B Dorshow, PhD MediBeacon
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date November 25, 2020
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		Number of participants with adverse events [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Official Title  ICMJE A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Retinopathy
  • Retinal Vein Occlusion
  • Diabetic Retinopathy
  • Macular Degeneration
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Richard B Dorshow, PhD 314-735-0967 rbdorshow@medibeacon.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008121
Other Study ID Numbers  ICMJE MB-200-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MediBeacon
Study Sponsor  ICMJE MediBeacon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard B Dorshow, PhD MediBeacon
PRS Account MediBeacon
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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