Verteporfin Therapy:
Comparing Data
A new Web-based tool lets you view and compare your success rate to that of other practices.
BY PETER K. KAISER, M.D.
If you treat patients with Visudyne therapy, you may have wondered how your outcomes compare with those of other doctors. Now there's an easy way to tell: You can enter your verteporfin treatment data at the Patient Registry, a Web-based, secure database including data from more than 100 practices.
An Internet Overview
The Patient Registry is actually a clinical trial, and evaluation of the data is ongoing. (It's not a closed database; however, as a clinical trial it requires Institutional Review Board oversight.) Investigators hope to discover whether usage and outcomes in the "real world" are similar to the TAP (Treatment of Age-related Macular Degeneration with Photodynamic Therapy) and VIP (Verteporfin in Photodynamic Therapy) clinical trials. As the database grows, it will provide much higher numbers than any standard clinical trial, making the data very informative.
The database allows you to view your own trends and outcomes and compare them to those of other U.S. physicians. You can look at multiple statistics, including visual outcomes, treatment applications and distribution of baseline data. You also can graph this information in various ways.
Among the questions the Patient Registry may help to answer are:
- What are your average treatment rate and outcomes versus the published data from clinical trials?
- Is there a difference between patients treated according to the TAP/VIP protocols and those who aren't? Which appears more effective?
- What are the outcomes of off-label treatments?
Getting the Bigger Picture
As of the end of April 2003, more than 1,000 patients were enrolled in the database, including both AMD and non-AMD patients. In the AMD group, the frequency of baseline vision distribution was skewed toward those with poor vision. Most had vision worse than patients in the TAP Investigation, and most had predominantly classic lesions.
For more information on joining the Patient Registry, please contact George Ritacco at (877) 791-4367 or at Registry@digitaldms.net.
Hope for Patients with Minimally Classic Lesions |
The latest data from the VIM (Visudyne in Minimally Classic) trial, presented at the Association for Research in Vision and Ophthalmology annual meeting, suggest that Visudyne therapy may be able to reduce the risk of vision loss in "wet" age-related macular degeneration (AMD) patients who have minimally classic lesions. This form of wet AMD was previously considered untreatable. The VIM Trial is a Phase II, multicenter study involving 117 patients. Twelve-month data from the trial indicate that: A Patients receiving Visudyne therapy showed a better mean change in visual acuity scores than patients receiving placebo (reduced fluence P=0.02; standard fluence P=0.08; all Visudyne combined P=0.01). This data confirmed 6-month trial results presented earlier this year at the annual meeting of the Macula Society. A Fewer Visudyne-treated patients developed predominantly classic choroidal neovascularization), compared with patients who received placebo. If this data is confirmed by further clinical studies, Visudyne therapy could become the first treatment to offer hope of reduced vision loss to wet AMD patients with minimally classic lesions. |