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

Официальное название

A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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
• Комбинированный продукт 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
• Комбинированный продукт 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
• Комбинированный продукт 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

Первичные конечные точки

• Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye [Срок оценки: From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks]

Вторичные конечные точки (1)

• Number of participants with adverse events [Срок оценки: From the time of study enrollment until the end of adverse event collection, up to 24 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of Michigan Kellogg Eye Center — Ann Arbor

Идентификаторы

NCT: NCT04008121 · MB-200-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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