METHODS AND COMPOSITIONS FOR PREVENTING THE PROGRESSION OF DIABETIC RETINOPATHY AND RELATED CONDITIONS
The invention provides methods, compositions, and kits containing a first therapeutic agent that is a substituted 2,3-dimethoxyquinone of Formula I, or a pharmaceutically acceptable salt thereof, for preventing the progression of diabetic retinopathy, diabetic macular edema, and/or other retinal disorders and/or other disorders.
1 . A method of preventing the progression of a diabetic retinal disease, comprising the steps of:
(a) identifying a human patient with diabetic retinal disease that would benefit from therapy that prevents the progression of the diabetic retinal disease; and
(b) orally administering to said human patient in need thereof a therapeutically effective amount of a first therapeutic agent to thereby prevent the progression of diabetic retinal disease, wherein the first therapeutic agent is a compound of Formula I or a pharmaceutically acceptable salt thereof.
2 . The method of claim 1 , wherein the diabetic retinal disease is diabetic retinopathy.
3 . The method of claim 2 , wherein step (a) comprises identifying a human patient with diabetic retinal disease that is mild or moderate non-proliferative diabetic retinopathy that would benefit from therapy that prevents progression of the diabetic retinal disease.
4 . The method of claim 2 , wherein step (a) comprises identifying a human patient with diabetic retinal disease that is moderate to moderately severe non-proliferative diabetic retinopathy that would benefit from therapy that prevents progression of the diabetic retinal disease.
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7 . The method of claim 3 , wherein preventing the progression of diabetic retinal disease comprises preventing an increase of three or more steps in the patient's Diabetic Retinopathy Severity Score.
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14 . The method of claim 2 , wherein the diabetic retinopathy is moderate diabetic retinopathy.
15 . The method of claim 2 , wherein the diabetic retinopathy is moderately severe to severe diabetic retinopathy.
16 . The method of claim 2 , wherein the diabetic retinopathy is non-proliferative diabetic retinopathy.
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19 . The method of claim 3 , wherein the first therapeutic agent is a calcium salt of compound of Formula I.
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28 . The method of claim 3 , wherein a first dose of the first therapeutic agent and a second dose of the first therapeutic agent are orally administered to the patient on the same day.
29 . The method of claim 3 , wherein the first therapeutic agent is orally administered to the patient in an amount of about 600 mg per day.
30 . The method of claim 3 , wherein about 300 mg of the first therapeutic agent is orally administered to the patient in the morning, and about 300 mg of the first therapeutic agent is orally administered to the patient in the evening.
31 . The method of claim 3 , wherein about 300 mg of the first therapeutic agent is orally administered to the patient, and then at a time that is from about 8 hours to about 16 hours later about 300 mg of the first therapeutic agent is orally administered to the patient.
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38 . The method of claim 3 , wherein the first therapeutic agent is orally administered to a patient only 1 time per day.
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40 . The method of claim 3 , wherein the first therapeutic agent is orally administered to the patient daily for at least 12 weeks.
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43 . The method of claim 3 , wherein the first therapeutic agent is orally administered to the patient daily for at least 48 weeks.
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66 . The method of claim 3 , wherein the patient has a DRSS level of 47 or 53 in at least one eye.
67 . The method of claim 2 , wherein the diabetic retinopathy is proliferative diabetic retinopathy or diabetic macular edema.
68 . A method of reducing the rate of progression of a diabetic retinal disease, comprising the steps of:
(a) identifying a human patient with diabetic retinal disease that would benefit from therapy that reduces the rate of progression of the diabetic retinal disease; and
(b) orally administering to said human patient in need thereof a therapeutically effective amount of a first therapeutic agent to thereby reduce the rate of progression of the diabetic retinal disease, wherein the first therapeutic agent is a compound of Formula I or a pharmaceutically acceptable salt thereof:
69 . A method of slowing clinically meaningful progression of a diabetic retinal disease, comprising the steps of:
(a) identifying a human patient with diabetic retinal disease that would benefit from therapy that slows clinically meaningful progression of the diabetic retinal disease; and
(b) orally administering to said human patient in need thereof a therapeutically effective amount of a first therapeutic agent to thereby slow clinically meaningful progression of the diabetic retinal disease, wherein the first therapeutic agent is a compound of Formula I or a pharmaceutically acceptable salt thereof:
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