Positive results from Visudyne(R) combination therapy study reported at Annual Macula Society ...(reatment said Michael Potter MD FRCSC A...),Health

VIA Study Design

This study was a single centre, Phase II randomized, controlled, double-masked clinical trial involving 36 patients who were assigned to one of three treatment groups
Group 1: Low fluence Visudyne followed by Avastin

Group 2: Very low fluence Visudyne followed by Avastin

Group 3: Avastin alone

Intravitreal bevacizumab was delivered within two hours of PDT at baseline. Patients returned monthly thereafter for best-corrected ETDRS visual acuity (VA) testing, optical coherence tomography (OCT), and ocular examination. Retreatment decisions were based primarily on OCT. PDT was administered at months 0, 3, 4, 5 or 6, with a minimum 3-month interval between verteporfin/sham PDT treatments.

VIA Study Results

Thirty-five of 36 enrolled patients completed the 6-month visit. The average number of Avastin treatments in Group 3 was 5.1, compared to 2.8 in Group 1 and 2.4 in Group 2. Over 6 months, patients who were treated in the Group 1 and Group 2 required significantly fewer treatments on average than those treated in Group 3 (p=0.005 and p<0.001, respectively). Each group experienced an average improvement in visual acuity at month 6, compared to baseline (Group 1: 6.3 letters, p>0.05; Group 2: 14.1 letters, p=0.003; and Group 3: 10.8 letters, p<0.001, respectively). Both combination therapy and mono therapy used in the study were well tolerated.

Additional Study Results Reported on Visudyne Combination Therapy

Additional data demonstrating the potential benefits of Visudyne combination therapy were reported today at the Macula Society conference by: Dr. William F. Mieler, investigator and Chairman of the Registry Oversight Board Committee for QLT's two Visudyne registry studies (RVT001 and RVT002);
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