Vaccination and Immunotherapy as New Therapeutic Modalities in the Treatment of Glaucoma

Abstract

This invention provides a method whereby a vaccine, particularly a vaccine based on a prophylactic or therapeutic AIDS/HIV vaccine, or other immune-reactive substance is administered to produce an immunologic response that decreases intraocular pressure or has a neuro-protective effect beneficial in the treatment of glaucoma patients. The invention may also be used as a provocative test to diagnose glaucoma as well as identify those patients at risk for developing glaucoma. The invention may also be used to prevent the development of glaucoma in patients deemed to be at high risk of developing glaucoma, such as glaucoma suspects or ocular hypertensive patients.

1 - 15 . (canceled) 
     
     
         16 . A method for determining if the injection of an immune-reactive substance reduces the intraocular pressure of a subject comprising measuring the intraocular pressure of the subject, administering to the subject a composition comprising an immune-reactive substance, and subsequently measuring the intraocular pressure of the subject to determine if said intraocular pressure is lowered is after said administration. 
     
     
         17 . The method of  claim 16  wherein the immune-reactive substance is selected from the group consisting of naked DNA, HIV proteins, live HIV vectors, HIV viruses, and a combination thereof 
     
     
         18 . The method of  claim 16  wherein the immune-reactive substance consists of one or more proteins. 
     
     
         19 . The method of  claim 16  wherein the immune-reactive substance consists of one or more nucleotides or polynucleotides. 
     
     
         20 . The method of  claim 16  wherein the immune-reactive substance consists of one or more prions. 
     
     
         21 . The method of  claim 16  wherein the immune-reactive substance consists of one or more amino acids. 
     
     
         22 . A method for therapeutic treatment of glaucoma or ocular hypertension comprising administering to a human subject a composition containing an effective amount of an immune-reactive substance to decrease intraocular pressure, wherein said subject has an intraocular pressure (TOP) of 22 mm Hg or greater. 
     
     
         23 . The method of  claim 22  wherein the immune-reactive substance is selected from the group consisting of naked DNA, HIV proteins, live HIV vectors, HIV viruses, and a combination thereof 
     
     
         24 . The method of  claim 16  further comprising performing a diagnostic test on the subject to determine the effect of said composition on reduction of IOP in said human subject. 
     
     
         25 . The method of  claim 24  wherein the diagnostic test comprises one or is more tests selected from the group consisting of slit lamp examination, gonioscopy, measuring intraocular pressure, visual field examination, cup-to-disk ratio determination, central corneal thickness determination, scanning laser polarimetry (SLP), and Heidelberg retina tomograph (HRT). 
     
     
         26 . The method of  claim 22  wherein the step of administering comprises systemic or local inoculation. 
     
     
         27 . The method of  claim 26  wherein systemic inoculation is performed by one or more of injection, inhalation, sublingual administration, subcutaneous administration, submucosal administration, or oral ingestion. 
     
     
         28 . The method of  claim 26  wherein the administering is a local inoculation and is performed in, or in the vicinity of, the eye. 
     
     
         29 . The method of  claim 26  wherein the administering is a local inoculation and is performed via intramuscular, intramedullary, intrathecal, intraventricular, or intraperitoneal routes. 
     
     
         30 . The method of  claim 22  wherein said effective amount of said effective amount of said immune-reactive substance is sufficient to reduce intraocular pressure to below 22 mm Hg. 
     
     
         31 . The method of  claim 22 , wherein the composition further includes additives selected from a group consisting of adjuvants, excipients, preservatives and combinations thereof 
     
     
         32 . The method of  claim 22 , wherein said human subject is treated with one or more additional administrations of an effective amount of an immune-reactive substance. 
     
     
         33 . The method of  claim 32 , wherein the additional administrations were administered after testing showed progression of glaucomatous damage or an increase is in intraocular pressure.