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C.A. Carvalho Recchia, J.S. Slakter, H. Rodriguez-Coleman, A. Ciardella, S. Negrao, F.M. Recchia, D. Orlock, J. Jerdan, P. Zilliox; Anecortave Acetate Administered as a Posterior Juxtascleral Administration in Patients with Subfoveal Age-Related Macular Degeneration (AMD) – the Role of the Digital Angiography Reading Center (DARC) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):5045.
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Purpose: The Digital Angiography Reading Center (DARC) was developed to provide rapid evaluation of digital angiographic images for use in clinical trials. Methods: Four masked, randomized clinical studies are underway to evaluate the effect of the angiostatic agent anecortave acetate administered as a posterior juxtascleral injection in patients with exudative AMD. The first trial was a monotherapy evaluation of anecortave acetate (30mg, 15mg or 3mg) versus placebo. Two additional monotherapy trials have been initiated, one in Europe and New Zealand, one in South/Central America, to evaluate the clinical efficacy of anecortave acetate 15mg compared to placebo. In addition, a phase III clinical study has been initiated in the US, Europe and Australia to compare the clinical efficacy of anecortave acetate to Visudyne PDT. The DARC plays a key role in each of these studies, utilizing state-of-the-art technological capabilities with both digital imaging (fluorescein and Indocyanine green angiography) and internet communication to provide rapid evaluation of these digital images via worldwide communication of clinical sites with the Reading Center. This evaluation includes determination of the extent of the subfoveal lesion as well as specific characteristics such as lesion size and amount of classic neovascularization, with measurements in mm2 as apposed to the best-fit estimates necessary for evaluations of film data. The DARC provides rapid evaluation of images which ensures that only eligible patients are enrolled in the trials, with follow-up evaluations to determine changes over time. Results: A comparison of baseline patient characteristics will be made across all ongoing studies, including lesion components (blood, lipid), proportion of classic and occult neovascularization, and total lesion size. Conclusions: Fundus imaging and angiographic data on AMD lesion changes in four ongoing studies are being evaluated by the DARC. These are the first multi-center clinical trials which have been designed to utilize a completely digital imaging protocol.
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