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Visudyne therapy is approved for the treatment of age-related maculardegeneration (AMD) in patients with predominantly classic subfoveal choroidalneovascularization. QLT Inc. is the manufacturer of Visudyne.
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Dr. Michael Potter, the investigator-sponsor of the verteporfin andbevacizumab (VIA) clinical trial, which was supported by QLT, presentedresults today at the 31st Annual Macula Society Meeting that is being heldthis week in Florida. The objective of the VIA study was to determine whetherVisudyne, at low or very low fluence rates, in combination with Avastin,reduces the average number of treatments required, compared to Avastin alone.
"We are very pleased with the clinical outcomes of this study. Our goalwas to see if it is possible to minimize the number of treatments whilemaintaining or improving visual acuity in patients with CNV secondary to AMD.At six months, virtually all the patients treated with the Visudynecombination therapy gained visual acuity with half the number of treatmentsrequired with Avastin monotherapy. These results are encouraging, and moreresearch continues to be done to evaluate the benefits of combination therapyin terms of helping patients improve their vision and also reducing the costof treatment," said Michael Potter, MD, FRCSC, Associate Professor, Departmentof Ophthalmology and Visual Sciences, Vancouver Hospital/University of BritishColumbia Eye Care Centre.
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 ofthree treatment groups
Intravitreal bevacizumab was delivered within two hours of PDT atbaseline. Patients returned monthly thereafter for best-corrected ETDRS visualacuity (VA) testing, optical coherence tomography (OCT), and ocularexamination. Retreatment decisions were based primarily on OCT. PDT wasadministered at months 0, 3, 4, 5 or 6, with a minimum 3-month intervalbetween verteporfin/sham PDT treatments.
VIA Study Results
Thirty-five of 36 enrolled patients completed the 6-month visit. Theaverage number of Avastin treatments in Group 3 was 5.1, compared to 2.8 inGroup 1 and 2.4 in Group 2. Over 6 months, patients who were treated in theGroup 1 and Group 2 required significantly fewer treatments on average thanthose treated in Group 3 (p=0.005 and p<0.001, respectively). Each groupexperienced an average improvement in visual acuity at month 6, compared tobaseline (Group 1: 6.3 letters, p>0.05; Group 2: 14.1 letters, p=0.003; andGroup 3: 10.8 letters, p<0.001, respectively). Both combination therapy andmono therapy used in the study were well tolerated.
Additional Study Results Reported on Visudyne Combination Therapy
Additional data demonstrating the potential benefits of Visudynecombination therapy were reported today at the Macula Society conference by:Dr. William F. Mieler, investigator and Chairman of the Registry OversightBoard Committee for QLT's two Visudyne registry studies (RVT001 and RVT002);Dr. Paolo Lanzetta, investigator for a triple therapy clinical study ofranibizumab, juxtascleral triamcinolone acetonide and Visudyne; an
