Methods for Treating or Preventing Ophthalmological Conditions
The present invention relates to methods for treating and preventing ophthalmological disease and disorders, comprising administering Antagonist A or another pharmaceutically acceptable salt thereof, optionally in combination with another treatment, to a subject in need thereof. The present invention also relates to methods for treating and preventing ophthalmological disease and disorders, comprising administering an anti-C5 agent (e.g., ARC1905), optionally in combination with another treatment, to a subject in need thereof.
1 . A method for treating or preventing wet age-related macular degeneration (wet AMD), comprising administering to a subject in need thereof (a) Antagonist A or another pharmaceutically acceptable salt thereof and (b) an VEGF antagonist, wherein (a) and (b) are administered in an amount that is effective for treating or preventing wet AMD, and wherein the administering occurs once every month, ±about seven days, for a first administration period of at least 3 consecutive months, followed by administering (a) and (b) for a second administration period at a frequency of at least every other month±about seven days beginning at two months±about seven days after the day of the last month of the first administration period on which (a) and (b) are administered.
2 . The method of claim 1 , wherein (a) and (b) are administered within about 60 minutes of each other.
3 . The method of claim 1 , wherein the VEGF antagonist is ranibizumab, bevacizumab, pegaptanib sodium, ESBA1008 or aflibercept.
4 . The method of claim 1 , wherein the VEGF antagonist is ranibizumab or bevacizumab, wherein (a) and (b) are administered at a frequency of once every month±about seven days during the second administration period and wherein the second administration period is at least about nine months.
5 . The method of claim 4 , further comprising measuring the subject's visual acuity.
6 . The method of claim 5 , further comprising administering to the subject (a) and (b) in an amount that is effective for treating or preventing wet AMD, until the subject's visual acuity on the last two of any three consecutive months is ≦a five-ETDRS-letter difference from the subject's visual acuity on the first of the three consecutive months.
7 . The method of claim 5 , further comprising administering to the subject (a) and (b) every other month in an amount that is effective for treating or preventing wet AMD, wherein the subject's visual acuity on the last two of any three consecutive months is 5 a five-ETDRS-letter difference from the subject's visual acuity on the first of the three consecutive months.
8 . The method of claim 7 , further comprising administering to the subject (a) and (b) every month in an amount that is effective for treating or preventing wet AMD, until the subject's visual acuity on the last two of any three consecutive months is ≦a five-ETDRS-letter difference from the subject's visual acuity on the first of the three consecutive months.
9 . The method of claim 1 , wherein the VEGF antagonist is aflibercept.
10 . The method of claim 1 , wherein the total number of months does not exceed 24.
11 . The method of claim 4 , wherein the subject has intraretinal or sub-retinal hemorrhage or a ≧50 μm increase in foveal intraretinal fluid at one month, ±about seven days, immediately following the second administration period.
12 . The method of claim 11 , further comprising: administering to the subject on each month±about seven days, beginning on the month that immediately follows the second administration period (a) and (b) in an amount that is effective for treating or preventing wet AMD, until the subject's visual acuity on the last two of any three consecutive months that follow the 12 consecutive months is ≦a five-ETDRS-letter difference from the subject's visual acuity on the first of the three consecutive months.
13 . The method of claim 12 , wherein the total number of months does not exceed 24.
14 . The method of claim 1 , wherein Antagonist A or another pharmaceutically acceptable salt thereof is administered intravitreally in an amount of about 1.5 mg/eye.
15 . The method of claim 4 , wherein the VEGF antagonist is bevacizumab and is administered intravitreally in an amount of about 1.25 mg/eye.
16 . The method of claim 9 , wherein the VEGF antagonist is administered intravitreally in an amount of about 2 mg/eye.
17 . The method of claim 4 , wherein the VEGF antagonist is ranibizumab and is administered intravitreally in an amount of about 0.5 mg/eye.
18 . The method of claim 1 , further comprising administering an anti-C5 agent.
19 . The method of claim 1 , further comprising administering (a) and (b) on a month in which the subject has intraretinal or sub-retinal hemorrhage or a ≧50 μm increase in foveal intraretinal fluid.
20 . A method for treating or preventing sub-retinal fibrosis, comprising administering to a subject in need thereof (a) Antagonist A or another pharmaceutically acceptable salt thereof in an amount that is effective for treating or preventing sub-retinal fibrosis.
21 . The method of claim 20 , further comprising administering to the subject (b) a VEGF antagonist, wherein (a) and (b) are administered in an amount that is effective for treating or preventing sub-retinal fibrosis.
22 . The method of claim 20 , wherein the subject has wet age-related macular degeneration (wet AMD).
23 . The method of claim 22 , wherein the sub-retinal fibrosis is associated with the wet AMD.
24 . The method of claim 20 , wherein administering Antagonist A or another pharmaceutically acceptable salt thereof results in a decrease in the size of sub-retinal hyper-reflective material (SHRM) as evidenced by spectral domain optical coherence tomography (SD-OCT) or results in stabilization of the subject's vision.
25 . The method of claim 20 , wherein Antagonist A or another pharmaceutically acceptable salt thereof is administered intravitreally in an amount of about 1.5 mg/eye.
26 . The method of claim 21 , wherein the VEGF antagonist is bevacizumab, ranibizumab, aflibercept, pegaptanib sodium or ESBA1008.
27 . The method of claim 26 , wherein the VEGF antagonist is bevacizumab and is administered intravitreally in an amount of about 1.25 mg/eye.
28 . The method of claim 26 , wherein the VEGF antagonist is aflibercept and is administered intravitreally in an amount of about 2 mg/eye.
29 . The method of claim 26 , wherein the VEGF antagonist is ranibizumab and is administered intravitreally in an amount of about 0.5 mg/eye.
30 . The method of claim 21 , further comprising administering an anti-C5 agent.
31 . A method for treating or preventing von Hippel-Lindau (VHL) disease, comprising administering to a subject in need thereof. Antagonist A or another pharmaceutically acceptable salt thereof in an amount that is effective for treating or preventing VHL disease.
32 . The method of claim 31 , further comprising administering a VEGF antagonist.
33 . The method of claim 31 , wherein Antagonist A or another pharmaceutically acceptable salt thereof is administered intravitreally in an amount of about 1.5 mg/eye.
34 . The method of claim 32 , wherein the VEGF antagonist is bevacizumab and is administered intravitreally in an amount of about 1.25 mg/eye.
35 . The method of claim 32 , wherein the VEGF antagonist is aflibercept and is administered intravitreally in an amount of about 2 mg/eye.
36 . The method of claim 32 , wherein the VEGF antagonist is ranibizumab and is administered intravitreally in an amount of about 0.5 mg/eye.
37 . The method of claim 32 , further comprising administering an anti-C5 agent.