Treatment of AMD in Stroke Patient
I received this question recently:
My 75 year old father has wet AMD in one eye and has lost vision in this.eye. He has had two treatments of Visudyne with poor results. He has been anxiously awaiting Avastin treatment (as we're from Canada, it has not been available here) and has recently traveled to the U.S. to seek advice.
Two weeks ago, he had a minor stroke and is now taking Coumadin. His new doctor has told him he is no longer a candidate for either Lucentis or Avastin because of his stroke. This doctor says that Visudyne is "overkill" in his case and recommends Macugen treatments. My dad is very nervous about bleeding within the eye with the Macugen. Could you please confirm that
a) the Macugen treatment is safe for a patient taking Coumadin; and
b) that a stroke definitely rules out Avastin or Lucentis as treatment for wetAMD.
Any other thoughts on the matter would be appreciated.
I would recommend Macugen. When Macugen, or anything for that matter, is injected into the eye, the pressure inside the eye increases. The pressure increase slows or even stops the flow of blood into the eye so there is little risk of hemorrhage from the injection. Macugen doesn’t increase the risk of hemorrhage from the neovascular membrane either. As the neovascularization atrophies, the risk of hemorrhage should decrease not increase.
My biggest concern with your father is that Coumadin® increases the risk of intraocular hemorrhage in eyes with wet AMD. Therefore the doctor who monitors his protime (a measure of Coumadin’s anticoagulant effect) should be told to keep the protime as low as possible yet still have the desired effect of decreasing the risk of a stroke. That usually means an INR (International Normalized Ratio) of around 2.0-2.5.
Why not Avastin or Lucentis since in studies they appear to result in better vision than Macugen? These drugs inhibit all forms of vascular growth factor whereas Macugen inhibits only one. There is concern that a small amount of Avastin and/or Lucentis can get out of the eye into the systemic circulation. In the large studies on Lucentis, the groups treated with the drug had a slightly higher, albeit overall very low, risk of heart attack than the control group. One eye doctor noted an effect of Avastin in the opposite eye of the one injected. The only way the Avastin could have gotten into the fellow eye is through the bloodstream.
Eyetech has also reported a patient who had a life-threatening allergic reaction after an injection of Macugen and we’ve seen severe skin rashes after injection. Avastin. Lucentis, and Macugen are very safe but we are becoming suspicious that they may have rare side-effects. So we have to weigh the possible benefits of these drugs with the risk. That begs the question as to the visual potential of your father’s eye? If he has done poorly after two Visudyne treatments maybe there is already scarring and the vision won’t get better with any treatment. If he has another good eye and he’s not well, maybe it would be best just to watch the better eye. Or maybe he could be treated again with Visudyne, (which he appears to tolerate well), to make sure the neovascularization dries up into an inactive scar. Please tell all of this to your father and in the end, he should be the one to make the decision. Good luck!
References:
1. Gragoudas ES, Adamis AP, Cunningham ET, Feinsod M, Guyer DR, VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for Neovascular Age-Related Macular Degeneration. New Engl J Med 2004; 351(27):2805-2816.
2. Avery RL, Pearlman J, Castellarin AA, Nasir MA, Patel A, Wendel RT, Reed B. Regression of retinal and iris neovascularization from diabetes following intravitreal bevacizumab (Avastin®). [ARVO 2006 poster 3860/B900]. Available from http://tinyurl.com/gbqsp, program number 3860.
3. Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N.Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology 2006; 113(4):623-632.
================
Reply from reader: Thank you to both Dr. Folk and Dr. Doan for responding to my question. I can't tell you how much it is appreciated. We feel like we have had a lot of conflicting advice, and you have really helped us to make a more informed decision on my dad's next treatment.
My 75 year old father has wet AMD in one eye and has lost vision in this.eye. He has had two treatments of Visudyne with poor results. He has been anxiously awaiting Avastin treatment (as we're from Canada, it has not been available here) and has recently traveled to the U.S. to seek advice.
Two weeks ago, he had a minor stroke and is now taking Coumadin. His new doctor has told him he is no longer a candidate for either Lucentis or Avastin because of his stroke. This doctor says that Visudyne is "overkill" in his case and recommends Macugen treatments. My dad is very nervous about bleeding within the eye with the Macugen. Could you please confirm that
a) the Macugen treatment is safe for a patient taking Coumadin; and
b) that a stroke definitely rules out Avastin or Lucentis as treatment for wetAMD.
Any other thoughts on the matter would be appreciated.
I would recommend Macugen. When Macugen, or anything for that matter, is injected into the eye, the pressure inside the eye increases. The pressure increase slows or even stops the flow of blood into the eye so there is little risk of hemorrhage from the injection. Macugen doesn’t increase the risk of hemorrhage from the neovascular membrane either. As the neovascularization atrophies, the risk of hemorrhage should decrease not increase.
My biggest concern with your father is that Coumadin® increases the risk of intraocular hemorrhage in eyes with wet AMD. Therefore the doctor who monitors his protime (a measure of Coumadin’s anticoagulant effect) should be told to keep the protime as low as possible yet still have the desired effect of decreasing the risk of a stroke. That usually means an INR (International Normalized Ratio) of around 2.0-2.5.
Why not Avastin or Lucentis since in studies they appear to result in better vision than Macugen? These drugs inhibit all forms of vascular growth factor whereas Macugen inhibits only one. There is concern that a small amount of Avastin and/or Lucentis can get out of the eye into the systemic circulation. In the large studies on Lucentis, the groups treated with the drug had a slightly higher, albeit overall very low, risk of heart attack than the control group. One eye doctor noted an effect of Avastin in the opposite eye of the one injected. The only way the Avastin could have gotten into the fellow eye is through the bloodstream.
Eyetech has also reported a patient who had a life-threatening allergic reaction after an injection of Macugen and we’ve seen severe skin rashes after injection. Avastin. Lucentis, and Macugen are very safe but we are becoming suspicious that they may have rare side-effects. So we have to weigh the possible benefits of these drugs with the risk. That begs the question as to the visual potential of your father’s eye? If he has done poorly after two Visudyne treatments maybe there is already scarring and the vision won’t get better with any treatment. If he has another good eye and he’s not well, maybe it would be best just to watch the better eye. Or maybe he could be treated again with Visudyne, (which he appears to tolerate well), to make sure the neovascularization dries up into an inactive scar. Please tell all of this to your father and in the end, he should be the one to make the decision. Good luck!
References:
1. Gragoudas ES, Adamis AP, Cunningham ET, Feinsod M, Guyer DR, VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for Neovascular Age-Related Macular Degeneration. New Engl J Med 2004; 351(27):2805-2816.
2. Avery RL, Pearlman J, Castellarin AA, Nasir MA, Patel A, Wendel RT, Reed B. Regression of retinal and iris neovascularization from diabetes following intravitreal bevacizumab (Avastin®). [ARVO 2006 poster 3860/B900]. Available from http://tinyurl.com/gbqsp, program number 3860.
3. Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N.Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology 2006; 113(4):623-632.
================
Reply from reader: Thank you to both Dr. Folk and Dr. Doan for responding to my question. I can't tell you how much it is appreciated. We feel like we have had a lot of conflicting advice, and you have really helped us to make a more informed decision on my dad's next treatment.
posted by James C. Folk, M.D. at 2:34 PM
1 Comments:
Dr. Folk,
Good article on current treatments for AMD. I would appreciate your take on Genaera's Evizon treatment now in clinical trials 2 and 3. It appears to be promising. They are about to begin a new trial to test the effectiveness of increased dosages. Any chance of you getting involved in the testing?
Thanks,
Rex
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