Biomarker for diagnosis, prognosis, assessment and therapy stratification
AssigneeThe University of Melbourne
InventorsLaura Elizabeth Downie, Holly Rose Chinnery, Alexis Ceecee Britten-Jones, Mengliang Wu, Haihan Jiao
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Abstract
The present disclosure relates to use of tear fluid neuropeptide Y (NPY) level for diagnosis, prognosis, assessment and therapy stratification of corneal nerve damage or loss, corneal neuropathy, corneal neuropathic pain, corneal neuralgia, ocular disease, or peripheral neuropathy.
Claims38
A method of diagnosing the presence of or pre-disposition for corneal nerve damage or loss in a subject, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) comparing the level of the NPY to a reference level of the NPY,
- wherein a decreased level of the NPY compared to the reference level is indicative of the presence of or pre-disposition for corneal nerve damage or loss.
A method of diagnosing the presence of or pre-disposition for corneal neuropathy, corneal neuropathic pain, or corneal neuralgia, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) comparing the level of the NPY to a reference level of the NPY,
- wherein a decreased level of the NPY compared to the reference level indicates that indicates that said subject is suffering from or is at risk of corneal neuropathy, corneal neuropathic pain, or corneal neuralgia.
A method of diagnosing the presence of or pre-disposition for an ocular disease, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) comparing the level of the NPY to a reference level of the NPY,
- wherein a decreased level of the NPY compared to the reference level indicates that indicates that said subject is suffering from or is at risk of developing an ocular disease.
A method of diagnosing the presence of or pre-disposition for peripheral neuropathy, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) comparing the level of the NPY to a reference level of the NPY,
- wherein a decreased level of the NPY compared to the reference level indicates that indicates that said subject is suffering from or is at risk of developing peripheral neuropathy.
A method of evaluating the level of corneal nerve damage or loss in a subject, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject
- b) correlating the level of the NPY with severity of corneal nerve damage or loss.
A method of evaluating the level of corneal neuropathy, corneal neuropathic pain, or corneal neuralgia, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating the level of the NPY with severity of corneal neuropathy, corneal neuropathic pain, or corneal neuralgia.
A method of evaluating the level of peripheral neuropathy, said method comprising the steps of:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating the level of the NPY with severity of peripheral neuropathy.
A method of prognosis of a subject having corneal nerve damage or loss, the method comprising:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating said level of NPY to likely outcome of said corneal nerve damage or loss.
A method of prognosis of a subject having corneal neuropathy, corneal neuropathic pain, or corneal neuralgia, the method comprising:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating said level of NPY to likely outcome of said corneal neuropathy, corneal neuropathic pain, or corneal neuralgia.
A method of prognosis of a subject having peripheral neuropathy, the method comprising:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating said level of NPY to likely outcome of said peripheral neuropathy.
A method of monitoring treatment efficacy of a subject having corneal nerve damage or loss, corneal neuropathy, corneal neuropathic pain, or corneal neuralgia, ocular disease, or peripheral neuropathy, the method comprising:
- a) determining the level of neuropeptide Y (NPY) in a tear fluid sample from the subject;
- and
- b) correlating said level of NPY to a reference level indicative of a responder or non-responder to the treatment, or comparing said level to a baseline level of NPY before initiation of treatment;
- and
- c) optionally, continuing treatment when the subject is determined to be a responder or has an increased level of NPY compared to the baseline level;
- or switching the treatment when the subject is determined to be a non-responder, wherein switching the treatment comprises increasing a dose of the treatment administered, adding one or more of agents to the treatment regimen, discontinuing the treatment and initiating a different treatment regimen.
Use of ocular tear fluid neuropeptide Y (NPY) as a biomarker for corneal nerve damage or loss, corneal neuropathy, corneal neuropathic pain, or corneal neuralgia, ocular disease, or peripheral neuropathy.
Dependencies are inferred from the claim text.