Pharmaceutical Compositions and Methods for Treating Age-Related Macular Degeneration with Melatonin Analogues

Abstract

Pharmaceutical compositions and methods for treating and/or preventing age-related macular degeneration with melatonin analogues are provided.

We claim: 
     
         1 . A method for treating and/or preventing age-related macular degeneration in a patient identified as in need thereof, wherein said method comprises identifying a patient in need of treatment for age-related macular degeneration, and administering a therapeutic amount of ramelteon to said patient. 
     
     
         2 . The method of  claim 1 , wherein the patient is identified by visual examination of the patient's eye. 
     
     
         3 . The method of  claim 1 , wherein the patient is identified by screening according to risk-factor criteria. 
     
     
         4 . The method of  claim 1  wherein said age-related macular degeneration is the dry form. 
     
     
         5 . The method of  claim 1  wherein said age-related macular degeneration is the wet form. 
     
     
         6 . The method of  claim 1  wherein said age-related macular degeneration occurs in one eye. 
     
     
         7 . The method of  claim 1  wherein said age-related macular degeneration occurs in two eyes. 
     
     
         8 . The method of  claim 1  wherein said administration of ramelteon is by an oral dosage form. 
     
     
         9 . The method of  claim 1  wherein said administration of ramelteon is by an indictable dosage form. 
     
     
         10 . The method of  claim 1  wherein said administration of ramelteon is by a surface absorbent dosage form. 
     
     
         11 . The method of  claim 10  wherein said administration of ramelteon is by a skin-patch dosage form. 
     
     
         12 . The method of  claim 10  wherein said administration of ramelteon is by a liquid, powder, ointment, paste, gel or cream dosage form. 
     
     
         13 . The method of  claim 1  wherein said ramelteon is administered in a dose of from 1 mg to 1000 mg. 
     
     
         14 . The method of  claim 1  wherein said ramelteon is administered in the form of an isolated metabolite of ramelteon, (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide, in a dose of from 1 mg to 1000 mg. 
     
     
         15 . The method of  claim 1  wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μg/L to 100 mg/L. 
     
     
         16 . The method of  claim 1  wherein said ramelteon is administered in a dose once daily. 
     
     
         17 . The method of  claim 16  wherein said ramelteon is administered in the evening. 
     
     
         18 . The method of  claim 16  wherein said ramelteon is administered prior to sleep. 
     
     
         19 . The method of  claim 1  wherein said ramelteon is administered in a dose twice daily. 
     
     
         20 . The method of  claim 1  wherein said ramelteon is administered in a dose more than twice daily. 
     
     
         21 . The method of  claim 19  wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μg/L to 100 mg/L. 
     
     
         22 . The method of  claim 20  wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μg/L to 100 mg/L. 
     
     
         23 . The method of  claim 1  further comprising administering photodynamic therapy. 
     
     
         24 . The method of  claim 1  further comprising administering a therapeutic amount of a pharmaceutical agent selected from the group consisting of bevacizumab, ranibizumab, melatonin, pegaptanib and combinations thereof. 
     
     
         25 . A method for treating and/or preventing age-related macular degeneration in a patient identified as in need thereof, wherein said method comprises administering a therapeutic amount of ramelteon to a patient in need of treatment for age-related macular degeneration. 
     
     
         26 . The method of  claim 25  wherein said ramelteon is administered in the form of an isolated metabolite of ramelteon, (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide, in a dose of from 1 mg to 1000 mg. 
     
     
         27 . The method of  claim 25  further comprising administering photodynamic therapy. 
     
     
         28 . The method of  claim 25  further comprising administering a therapeutic amount of a pharmaceutical agent selected from the group consisting of bevacizumab, ranibizumab, melatonin, pegaptanib sodium and combinations thereof. 
     
     
         29 . A pharmaceutical composition comprising (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide and a pharmacologically acceptable carrier. 
     
     
         30 . (S)—N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide.