May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
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)
Author Affiliations & Notes
  • C.A. Carvalho Recchia
    Digital Angiography Reading Center, New York, NY, United States
  • J.S. Slakter
    Digital Angiography Reading Center, New York, NY, United States
  • H. Rodriguez-Coleman
    Digital Angiography Reading Center, New York, NY, United States
  • A. Ciardella
    Digital Angiography Reading Center, New York, NY, United States
  • S. Negrao
    Digital Angiography Reading Center, New York, NY, United States
  • F.M. Recchia
    Digital Angiography Reading Center, New York, NY, United States
  • D. Orlock
    Digital Angiography Reading Center, New York, NY, United States
  • J. Jerdan
    Alcon Research Ltd., Ft. Worth, TX, United States
  • P. Zilliox
    Alcon Research Ltd., Ft. Worth, TX, United States
  • Footnotes
    Commercial Relationships  C.A. Carvalho Recchia, None; J.S. Slakter, Alcon Research, Ltd. F, R; H. Rodriguez-Coleman, None; A. Ciardella, None; S. Negrao, None; F.M. Recchia, None; D. Orlock, None; J. Jerdan, Alcon Research Ltd. E; P. Zilliox, Alcon Research Ltd. E.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 5045. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Abstract: : 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.

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: tre • imaging/image analysis: clinical 
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