RetinopathyEarly Phase 1NCT04008121
Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
A Early Phase 1 study testing Fluorescein sodium and Zeiss FF450 fundus camera, MB-102 and Zeiss FF450 fundus camera and Fluorescein sodium and commercially available optical angiography imaging system in people with Retinopathy and Retinal Vein Occlusion, run by MediBeacon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinopathy, Retinal Vein Occlusion, Diabetic Retinopathy
- What is being tested?
- Fluorescein sodium and Zeiss FF450 fundus camera, MB-102 and Zeiss FF450 fundus camera and Fluorescein sodium and commercially available optical angiography imaging system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
Julie M Rosenthal, MD
About this study
Official title: A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
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.
Read the 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.
- Being tested
- 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
- Keywords
- Fluorescein angiography
- Medical subject headings
- Retinal Diseases, Retinal Vein Occlusion, Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein sodium and Zeiss FF450 fundus cameraCombination product
Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants
MB-102 and Zeiss FF450 fundus cameraCombination product
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
Fluorescein sodium and commercially available optical angiography imaging systemCombination product
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
MB-102 and commercially available optical angiography imaging systemCombination product
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 group | Role | What they receive |
|---|---|---|
| Adult participants with normal or diseased eyes | Experimental | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks
Secondary outcomes (1)
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.
Measured: From the time of study enrollment until the end of adverse event collection, up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008121
- Sponsor's protocol ID
- MB-200-01
- Status last verified
- Feb 2026
- First submitted
- 22 May 2019
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
- ClinicalTrials.gov ID
- NCT04008121
- Acronym / sponsor ID
- MB-200-01
- Keywords
- Fluorescein angiography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult participants with normal or diseased eyes | Experimental | 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 system500 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years - male or female
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein sodium and Zeiss FF450 fundus cameraFluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants | Combination product | Adult participants with normal or diseased eyes |
| MB-102 and Zeiss FF450 fundus cameraMB-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 | Adult participants with normal or diseased eyes |
| Fluorescein sodium and commercially available optical angiography imaging systemFollowing 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 | Adult participants with normal or diseased eyes |
| MB-102 and commercially available optical angiography imaging systemFollowing 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 | Adult participants with normal or diseased eyes |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard B Dorshow, PhD study director
MediBeacon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluorescein sodium and Zeiss FF450 fundus camera, MB-102 and Zeiss FF450 fundus camera and Fluorescein sodium and commercially available optical angiography imaging system in people with Retinopathy and Retinal Vein Occlusion, run by MediBeacon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard B Dorshow, PhD (314-735-0967, rbdorshow@medibeacon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.