Health TrialsbyHealthPanel

A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma

ConditionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22+
SponsorAmydis Inc.

About this trial

The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of primary open angle glaucoma in both eyes

Able to fixate

Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam

Disqualifiers

Participants unable to read or write

Ocular media is not sufficiently clear to obtain acceptable quality images

Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)

Trial design

Design model

Parallel

Treatments tested in this trial

  • AMDX-2011P

    Drug

    AMDX-2011P single bolus injection intravenous for diagnostic review

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: AMDX-2011P 50 mgExperimental treatment 1 intervention
Group B: AMDX-2011P 100 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AMDX-2011P Adverse Events Profile

Incidence, nature and severity of AEs/SAEs

Time frame
8 days

Secondary outcomes

1

Concentration of AMDX-2011P

Plasma PK Concentration (CMax)

Time frame
2 hours
2

Pharmacokinetic Analysis of AMDX-2011P

Area under the plasma versus time curve (AUC)

Time frame
2 hours
3

Biological Activity

Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amydis Inc.

Lead sponsor

Source ClinicalTrials.gov
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