Functional biomarkers for statin therapy in age-related macular degeneration (AMD)
AssigneesApeliotus Technologies, Inc., Massachusetts Eye and Ear Infirmary
InventorsJohn G. Edwards, Joan W. Miller, Demetrios Vavvas
Life of this patent
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Abstract
Methods of using visual functions such as dark adaptation, low luminance visual acuity, low luminance deficit, contrast sensitivity and scotopic sensitivity as functional biomarkers for statin therapy in AMD. These biomarkers can be used, for example, to support clinical trials of statin therapy for AMD by identifying participants more likely to respond, by providing an early indication of response, or by serving as an endpoint; or to support treatment of AMD patients with statins by identifying patients more likely to respond, by providing an early indication of responders vs. non-responders, or by confirming a treatment benefit.
Claims36
A method for determining the effectiveness of treating a subject having age-related macular degeneration (AMD) in a clinical trial of a statin therapy for AMD, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject having AMD, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- b. determining a baseline value for the subject from the one or more measurements of step a;
- c. administering the statin therapy to the subject having AMD after step a;
- d. measuring the one or more functional biomarkers in the subject at one or more later time points after step c;
- e. determining a corresponding subsequent value for the subject from the one or more measurements of step d;
- f. using a comparison of the subsequent value to the baseline value or an earlier subsequent value as a clinical trial endpoint to determine the effectiveness of the treatment;
- and
- g. taking an action based on the clinical trial endpoint.
A method for stratifying a plurality of subjects who have age-related macular degeneration (AMD) and are participating in a clinical trial of a statin therapy for treatment of AMD, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in each of the plurality of subjects, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- b. determining a subject value for each of the plurality of subjects from the one or more measurements of step a to provide a subject value for each of the plurality subjects;
- c. stratifying the plurality of subjects based on the subject values;
- and
- d. administering the statin therapy to the plurality of subjects stratified in step c.
A method for identifying an early indication of a response to treating a subject having age-related macular degeneration (AMD) in a clinical trial of a statin therapy for AMD, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject having AMD, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- b. determining a baseline value for the subject from the one or more measurements of step a;
- c. administering the statin therapy to the subject having AMD after step a;
- d. measuring the one or more functional biomarkers in the subject at one or more later time points after step c;
- e. determining a corresponding subsequent value from the one or more measurements of step d;
- and
- f. identifying the early indication of a response to the statin therapy in the subject if a comparison of the subsequent value to the baseline value or an earlier subsequent value satisfies an early indication criteria.
A method for selecting or identifying a subject having age-related macular degeneration (AMD) for participation in a clinical trial of a statin therapy for AMD, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- b. determining a subject value for the subject from the one or more measurements of step a;
- c. comparing the subject value to a corresponding reference range;
- d. selecting or identifying the subject for participation if the subject value is within the corresponding reference range;
- and
- e. administering the statin therapy to the subject selected or identified for participation in step d.
A method for treating a subject suffering from age-related macular degeneration (AMD) with a statin, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject;
- b. determining a baseline value for the subject from the one or more measurements of step a;
- c. administering a statin treatment to the subject at an initial statin dose;
- d. measuring the one or more functional biomarkers in the subject at one or more later time points, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- e. determining a subsequent value for the subject from the one or more measurements of step d;
- and
- f. making a treatment decision based on the subsequent value and the baseline value or the subsequent value and an earlier subsequent value, wherein the treatment decision is:
- i. continuing administering the statin treatment without change;
- ii. continuing administering the statin treatment with an increase in the dose of the statin being administered as compared to the initial dose or decrease in the dose of the statin being administered as compared to the initial dose;
- iii. continuing administering statin treatment with a different statin either at the same equivalent dose as compared to the initial dose, a higher equivalent dose as compared to the initial dose, or a lower equivalent dose as compared to the initial dose;
- or
- iv. discontinuing the statin treatment.
A method of selecting and treating a subject suffering from age-related macular degeneration (AMD), the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- b. determining a subject value for the subject from the one or more measurements of step a;
- c. comparing the subject value to a corresponding reference range;
- d. selecting the subject for treatment with the statin therapy if the subject value falls within the reference range or not selecting the subject for treatment with the statin therapy if the subject value falls outside the reference range;
- and
- e. administering the statin therapy to the subject selected for treatment in step d, thereby treating said AMD in said subject.
A method for treating a subject suffering from age-related macular degeneration (AMD) with a statin, the method consisting of the steps of:
- a. measuring one or more functional biomarkers in the subject;
- b. determining a baseline value for the subject from the one or more measurements of step a;
- c. administering a statin treatment to the subject at an initial statin dose;
- d. measuring the one or more functional biomarkers in the subject at one or more later time points, wherein the functional biomarker is a visual function other than normal luminance visual acuity;
- e. determining a subsequent value for the subject from the one or more measurements of step d;
- and
- f. administering a statin treatment to the subject based on the subsequent value and the baseline value or the subsequent value and an earlier subsequent value, thereby treating said AMD in said subject.
Dependencies are inferred from the claim text.