Article
ANti-VEGF antibody in the treatment of predominantly classic choroidal neovascularization in AMD (Lucentis Phase III, FVF 2587 ANCHOR-Study)
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Published: | September 22, 2004 |
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The ANCHOR-Study compares the efficacy and safety of intravitreal injections with Ranibizumab (=rhuFAB V2 =Lucentis) versus photodynamic therapy in patients with predominantly classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). In a multicenter, randomized, prospective, controlled phase III trial a total of 426 patients with predominantly classic CNV in AMD will be randomised into 3 groups. Each patient is followed for 24 months. Ranibizumb will be administered intravitreally as either 0.3 mg (Group 1) or 0.5 mg (Group 2) every month for a total of 24 injections. In addition, both groups will receive sham PDT treatment. Group 3 will be given Sham injections every months, but will receive PDT treatment with Verteporfin. PDT or Sham PDT is given at day 1, and the necessity for further PDT treatment is evaluated every 3 months. Efficacy outcome measures are EDTRS visual acuity, Visual Function Questionnaire (VFQ-25), and lesion characteristics on fluorescein angiography and optical coherence tomography.