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

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ClinicalTrials.gov Identifier: NCT04008121
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
MediBeacon

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008121


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 Not yet recruiting
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

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Responsible Party: MediBeacon
ClinicalTrials.gov Identifier: NCT04008121     History of Changes
Other Study ID Numbers: MB-200-01
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by MediBeacon:
Fluorescein angiography
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Retinal Vein Occlusion
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis