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Dye

MB-102 Dye for Retinal Disorders

Phase < 1

Waitlist Available

Research Sponsored by MediBeacon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial

Be older than 18 years old

Must not have

Prior history of seizures

Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of study enrollment until the end of adverse event collection, up to 24 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new dye is safe and produces clear images compared to the current standard dye used in a diagnostic test for retinal problems.

Who is the study for?

This trial is for adults over 18 with retinal or choroidal vascular diseases who can follow the study rules. Women must not be pregnant and willing to use birth control, and men must agree to contraception post-dose. It's not for those with conditions affecting eye imaging, in other trials, or unstable health.

What is being tested?

The study compares a new dye called MB-102 against a standard dye, fluorescein sodium, in producing eye images using different cameras. The goal is to assess MB-102's safety and the quality of images it provides for diagnosing and monitoring retinal diseases.

What are the potential side effects?

Potential side effects may include allergic reactions similar to those from known dyes like fluorescein sodium such as itching or hives. Severe reactions could involve anaphylaxis but are rare. Participants' tolerance will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and will use birth control during the trial if I can have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures in the past.

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I have eye conditions that could affect taking detailed pictures of the back of my eye.

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I am not pregnant, breastfeeding, planning to become pregnant, or unwilling to use contraception if of childbearing potential.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of study enrollment until the end of adverse event collection, up to 24 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of study enrollment until the end of adverse event collection, up to 24 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of study enrollment until the end of adverse event collection, up to 24 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye

Secondary study objectives

Number of participants with adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adult participants with normal or diseased eyesExperimental Treatment4 Interventions

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

0 / 4Eligibility criteria met