Clinical Trials

In the year 2000, the FDA approved Visudyne for use on the basis of 2 pivotal clinical trials. Conducted at 22 medical centers throughout North America and Europe and involving more than 600 patients, these trials comprised the TAP Investigation, 2 randomized clinical studies that compared the effects of verteporfin therapy to the effects of placebo therapy in several patient populations, including patients with predominantly classic subfoveal CNV secondary to wet AMD.^3,4

In the TAP Investigation, patients were randomly assigned to either verteporfin therapy or placebo therapy and then observed as often as every 3 months for up to 2 years with baseline and follow-up examinations that included best-corrected visual acuity following standardized protocol refraction and visual acuity determination, as well as stereoscopic color fundus photographs and fluorescein angiograms.^3,4

When protocol was followed, investigators found that patients in the TAP Investigation received an average of 3.4 treatments in the first year of therapy and 2.0 treatments the second year.² Although the number of treatments per patient sometimes varied, a “full course of therapy” was considered complete when the patient was no longer presenting with leakage or bleeding on angiography.

From these studies, investigators issued a series of reports. For detailed descriptions of the first 3 reports, click on the links below.

TAP Report 1 — 1-Year Results for Visual Acuity Outcomes

TAP Report 2 — 2-Year Results for Visual Acuity and Leakage Outcomes

TAP Report 3 — Additional Information Regarding Baseline Lesion Composition’s Impact on Vision Outcomes

Results from the 2-year TAP Investigation indicate that a full course of Visudyne therapy can help reduce vision loss and control leakage and lesion progression.²