Back to resultsFeasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Primary Purpose
Retinopathy, Retinal Vein Occlusion, Diabetic Retinopathy
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluorescein sodium and Zeiss FF450 fundus camera
MB-102 and Zeiss FF450 fundus camera
Fluorescein sodium and commercially available optical angiography imaging system
MB-102 and commercially available optical angiography imaging system
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinopathy focused on measuring Fluorescein angiography
Eligibility Criteria
Inclusion Criteria:
Age > 18 years - male or female
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial
- 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
Sites / Locations
- University of Michigan Kellogg Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adult participants with normal or diseased eyes
Arm Description
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
Outcomes
Primary Outcome Measures
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
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
Number of participants with adverse events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04008121
Brief Title
Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Official Title
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediBeacon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy, Retinal Vein Occlusion, Diabetic Retinopathy, Macular Degeneration
Keywords
Fluorescein angiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult participants with normal or diseased eyes
Arm Type
Experimental
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Fluorescein sodium and Zeiss FF450 fundus camera
Intervention Description
Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants
Intervention Type
Combination Product
Intervention Name(s)
MB-102 and Zeiss FF450 fundus camera
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
Fluorescein sodium and commercially available optical angiography imaging system
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
MB-102 and commercially available optical angiography imaging system
Intervention Description
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 Measure Information:
Title
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
Description
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.
Time Frame
From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Time Frame
From the time of study enrollment until the end of adverse event collection, up to 24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 18 years - male or female
Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard B Dorshow, PhD
Phone
314-735-0967
Email
rbdorshow@medibeacon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Dorshow, PhD
Organizational Affiliation
MediBeacon
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannis M Paulus, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
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