Central Carolina Surgical Eye Associates P.A.

Visudyne Photodynamic Therapy For the Treatment of
Wet Macular Degeneration Available Now
At Southeastern Eye Center
April 13, 2000 FDA Press Release-Approves Treatment
For Wet Macular Degeneration

Photodynamic Therapy for Macular Degeneration

by John D. Matthews M.D., FAAO

Photodynamic Therapy (PDT) is a new treatment for Age Related Macular Degeneration (AMD).  According to an article in the October 1999 issue of Archives of Ophthalmology PDT with Visudyne can stabilize vision and significantly reduce the risk of vision loss in certain patients with the “Wet” form of AMD.  Patients treated with Visudyne were 34% more likely to preserve their vision than patients who were not treated.  This study, called the TAP study (Treatment of AMD with Photodynamic therapy) enrolled 609 patients to either receive treatment or placebo.  The investigators did not know which patients were receiving treatment or placebo.  After one year, the patients who were treated with Visudyne and PDT were more than twice as likely to have improved vision. 

All of the patients in the study had the “Wet” form of AMD. (see What is age related macular degeneration? ) Visudyne and PDT (see Frequently Asked Questions) were well tolerated and no safety concerns were identified by the Data and Safety Monitoring Committee.  2.7% of the patients experienced transient photosensitivity reactions during the first 24 hours.  Only 2% of patients withdrew from the study. 

The treatment consists of a ten minute injection of Visudyne into the arm vein.  The dye concentrates in the “wet” area of leakage beneath the vision center.  A new non-thermal laser light is then shined into the eye to activate the dye. The entire treatment is done as an outpatient.   The activated dye causes regression of the leakage in most cases.  The leaking area can regress without damaging the overlying retina.  Retreatments may be needed every 3 months until all of the leakage has stopped.  The treatment dose of 83 seconds of laser exactly 15 minutes after an intravenous injection of 6mg/m2 of Visudyne was meticulously determined in animal studies.  

The detailed logistics are complex and comprehensive training is required in patient selection, determination of dose regimen, drug administration and timed laser application.  A Visudyne hotline is available for further information 1-800-821-2450, or visit the website sponsored by CIBA Vision here, www.visudyne.com

April 13, 2000 FDA Press Release-Approves Treatment
For Wet Macular Degeneration

Southeastern Eye Center
3312 Battleground Avenue
Greensboro, North Carolina
27410
Toll Free: 1-800-632-0428
or call: 1-336-282-5000


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