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AMDX-2011P 50 mg for Glaucoma

Phase 2
Recruiting
Research Sponsored by Amydis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of primary open angle glaucoma in both eyes
Able to fixate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights

Study Summary

This trial aims to determine if AMDX-2011P can be used to detect amyloid deposits in the retina of individuals with Primary Open Angle Glaucoma (POAG).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with open angle glaucoma in both eyes.
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I can focus my eyesight on a specific point.
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I have glaucoma damage in both eyes confirmed by an eye exam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AMDX-2011P Adverse Events Profile
Secondary outcome measures
Biological Activity
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P

Trial Design

2Treatment groups
Experimental Treatment
Group I: AMDX-2011P 50 mgExperimental Treatment1 Intervention
AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
Group II: AMDX-2011P 100 mgExperimental Treatment1 Intervention
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Find a Location

Who is running the clinical trial?

Amydis Inc.Lead Sponsor
2 Previous Clinical Trials
61 Total Patients Enrolled
David BingamanStudy DirectorAmydis Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being actively recruited for this research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking patients. The trial was initially posted for recruitment purposes on December 7th, 2023 and has been recently updated as of January 23rd, 2024. For this study, a total of 50 participants will be admitted at a single designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, the data available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on December 7th, 2023, and it was last updated on January 23rd, 2024. For this study, they aim to recruit a total of 50 individuals from one designated site."

Answered by AI

What are the potential risks and adverse effects associated with a dosage of 50 mg of AMDX-2011P for patients?

"Based on our evaluation, the safety of AMDX-2011P 50 mg is estimated to be at level 2. This assessment is derived from it being a Phase 2 trial where some evidence suggests its safety, but there is currently no data supporting its efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Global Research Management
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I hope that my disease number one will be able to help others not have to go through what I’m going through and number two hopes that my vision will improve.
PatientReceived 2+ prior treatments
~0 spots leftby May 2024