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

Overview

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.

Interventions

• 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

• 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]

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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• University of Michigan Kellogg Eye Center — Ann Arbor

Identifiers

NCT: NCT04008121 · MB-200-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗