MB-102 and Zeiss FF450 fundus camera for Diabetic Retinopathy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan Kellogg Eye Center, Ann Arbor, MI
Diabetic Retinopathy+4 More
MB-102 and Zeiss FF450 fundus camera - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new dye may help improve the ability to see blood vessels in the eye.

See full description

Eligible Conditions

  • Diabetic Retinopathy
  • Retinal Disorders
  • Branch Vein Occlusion
  • Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetic Retinopathy

Study Objectives

This trial is evaluating whether MB-102 and Zeiss FF450 fundus camera will improve 1 primary outcome and 1 secondary outcome in patients with Diabetic Retinopathy. Measurement will happen over the course of From the time of fluorescein sodium administration through optical angiography study completion, up to 2 weeks.

Week 2
Binary assessment by the Principal Investigator of the feasibility of MB-102 imaging as compared to fluorescein dye
Day 24
Number of participants with adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetic Retinopathy

Trial Design

1 Treatment Group

Adult participants with normal or diseased eyes
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. MB-102 And Zeiss FF450 Fundus Camera is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Adult participants with normal or diseased eyes500 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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the time of study enrollment until the end of adverse event collection, up to 24 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the time of study enrollment until the end of adverse event collection, up to 24 days for reporting.

Closest Location

University of Michigan Kellogg Eye Center - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Males must be willing to practice abstinence or use a condom from the time they take the drug until at least seven days after the dose. show original
At least five participants will have a current history of retinal or choroidal vascular diseases. show original
People who are willing to comply with the study requirements. show original
A person has to be 18 years old or older in order to be considered a male or female. show original
Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial
Participants who have signed an informed consent form

Patient Q&A Section

What are the signs of retinal diseases?

"Patients who present with a sudden headache or facial pain should be examined for the presence of retinal disease. Tension-type retinal hemorrhages or disc swelling due to retinal pathology should be considered and retinal specialists should be contacted. Although it is difficult to diagnose some retinopathies, a correct diagnosis can significantly aid in patient management." - Anonymous Online Contributor

Unverified Answer

What are common treatments for retinal diseases?

"At present, no medications can cure retinal diseases completely. Nevertheless, many doctors prescribe treatment in an attempt to prolong or improve sight for patients. This article will help doctors to gain a better understanding of the available treatments." - Anonymous Online Contributor

Unverified Answer

Can retinal diseases be cured?

"Findings from a recent study suggest that curing of the underlying disease might help to manage and reduce the severity of the symptoms of retinal diseases." - Anonymous Online Contributor

Unverified Answer

How many people get retinal diseases a year in the United States?

"More than 1.2 million Americans, or 3.9 percent of the total population, were diagnosed with some form of retinal disease during the 90 days following their purchase of a new prescription drug or over the counter drug. Of these conditions, 1.4 million cases (3.1 percent) met the eligibility criteria for the Aged Medicare-only Benefits Program. About 8,000 people per year were diagnosed with an incident retinal disease." - Anonymous Online Contributor

Unverified Answer

What causes retinal diseases?

"The pathogenesis of retinal diseases has been traced to a combination of environmental and genetic factors. However, the role of environmental factors in the aetiology of the majority of hereditary retinal defects remain to be clarified." - Anonymous Online Contributor

Unverified Answer

What is retinal diseases?

"This chapter deals with what the retina is, the light that the retina receives, how this light is transmitted from the retina to the visual cortex, and the diseases of the retina.\n\nThis chapter comprises the eye system. The eye is a hollow organ covered by the transparent membrane of the cornea. The structure and function of the human eye are the subject of the next chapter (Human Eye System).\n\nThe eye is a hollow organ that contains several layers of transparent tissue, including the cornea (anterior cornea), the sclera (middle cornea), and the retina (posterior cornea)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving mb-102 and zeiss ff450 fundus camera?

"There are other clinical trials registered by mb-102, including one involving an AAV virus vector called Mb-AVEX-TAT. ZF400/402 fundus cameras are other cameras being investigated by mb-102. There does not seem to be any more clinical trials registered in the US at the time of writing than those registered by mb-102 in the EU or other countries. This is an open publication and not all clinical trials have been registered. To find full text Clinical Trial Registers, visit [www.researchgate." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in mb-102 and zeiss ff450 fundus camera for therapeutic use?

"A fundus camera is a useful tool for ophthalmologists and optometrists when treating RP patients, in detecting early retinal dystrophy and in monitoring disease progression, especially in the case of ocular hypertension and neovascularization in advanced disease." - Anonymous Online Contributor

Unverified Answer

What is mb-102 and zeiss ff450 fundus camera?

"Mb-102 can serve as a useful complementary imaging modality in the evaluation of central retinal artery occlusive and posterior branch retinal vein occlusive diseases. A single photograph of the macula is sufficient for assessing these findings." - Anonymous Online Contributor

Unverified Answer

Does mb-102 and zeiss ff450 fundus camera improve quality of life for those with retinal diseases?

"This is the first reported study that shows clinical correlation between OCT and funduscopy in detecting retinal disease in patients. Mb-102 and FF450 fundus camera images showed comparable quality of life satisfaction and improvements to the overall eye function over time in patients with retinal diseases." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of retinal diseases?

"Primary eye disease were most commonly found in people with systemic disease such as diabetes, renal or cardiac disease, cancer or infection. Infectious causes were the most common cause of retinal disease worldwide." - Anonymous Online Contributor

Unverified Answer

What is the latest research for retinal diseases?

"The major advancements in the fields of treatment, research, and diagnosis of retinal diseases have provided the foundation for much of the knowledge about retinal diseases published since 2010. Clinical trials are the best source to find up-to-date research about retinal diseases. Clinical trials are also the best sources of information about retinal diseases for patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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