To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Monthly Lucentis Reduces Need for Photodynamic Therapy While Improving Visual Acuity: Presented at AAO URL: http://www.pslgroup.com/dg/217136.htm Doctor's Guide November 13, 2007
By Cameron E. Johnston NEW ORLEANS, LA -- November 13, 2007 -- A trial comparing the use of verteporfin photodynamic therapy alone (PDT) against photodynamic therapy in combination with monthly injections of ranibizumab has demonstrated superior improvements in visual acuity compared with PDT monotherapy. The study also showed that use of PDT could be reduced significantly when supplemented by ranibizumab treatments. The results of the study were presented here on November 9 in the Retina Sub-specialty Day session of the annual meeting of the American Academy of Ophthalmology (AAO). The presenter was Paulo Lanzetta, MD, Department of Ophthalmology, University of Udine, Udine, Italy. The study enrolled a total of 161 patients, of whom 56 were to receive verteporfin PDT treatment every 3 months. A second group of 105 patients were to receive the same PDT treatment followed 1 week later by an injection of ranibizumab. In this group, the ranibizumab was administered every month for a total of 24 injections. PDT in both groups was given as needed, when fluorescein angiography revealed any signs of vascular leakage. Midway through the trial, the formulation of ranibizumab was changed and the dosing schedule was altered so it was given 21 days after the PDT treatment. The primary endpoints in the study were the safety, efficacy and tolerability of the combination therapy as compared with the monotherapy. At the end of 24 months, the changes in visual acuity clearly favoured the combination therapy arm over PDT monotherapy arm. The mean change in visual acuity for the combination therapy arm was an increase of 4.9 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters over baseline, whereas the mean changes in the PDT monotherapy arm was a decrease of 8.2 letters from baseline. The final between-group difference was 12.4 letters which was highly statistically significant (P >.0001) Approximately one quarter of patients in the combination therapy group gained at least 3 lines of visual acuity. Even some patients who were considered legally blind at enrolment were able to realise improvements in vision. The same could not be said for patients who were in the monotherapy arm. Over the first 12 months of the study, approximately 90% of patients on combination therapy maintained or improved vision, compared with 68% of patients in the PDT alone arm. These improvements were not as robust after 2 years of followup, but the between-group difference remained constant. Overall, 90% of patients in the PDT group and 29% of patients in the combination therapy arm required retreatments with PDT. The average number of treatments, in fact, was 1.4 in the combination therapy arm and 4 for those in the monotherapy arm. This indicates that the ranibizumab is not only preventing neovascularisation, but it is also eradicating some of the existing growth of new blood vessels. The only significant adverse events occurred in patients who received the dual therapy, who experienced significantly more uveitis compared with patients who received PDT alone (9.5%). However, Dr. Lanzetta said that this does not provide doctors with enough evidence to conclude that the uveitis was caused by the dual therapy or was somehow related to the use of ranibizumab. The rate of uveitis was more or less the same regardless of which formulation of ranibizumab was used, he added. Dr. Lanzetta concluded that this study shows that the use of ranibizumab may reduce the need for treatments with PDT, which translates into "greater efficacy for the patient, the physicians, caregivers, and the healthcare system as a whole." Dual treatment might also permit more tailoring of individual patient treatments by limiting PDT use only to those who show angiographic leakage, he said. [Presentation title: Lessons Learned from the FOCUS Trial.] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.