Article
Statistical analyses, modelling of response characteristics, saturation of therapy and optimum of AMD treatment with less than 12 injections of Rainibizumab/year
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Published: | September 21, 2010 |
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Background: Results of randomized studies provide evidence that concepts based on less than 12 injections/year are not sufficient to conserve functional gain of the loading phase. It was the intention of these analyses to gain new information useful for the design of novel therapy concepts.
Material and methods: 104 patients were treated following low re-treatment threshold criteria (any grade of visual loss or OCT signs of disease activity) and re-examined monthly. Evaluation included: classification of responder status, relation of visual acuity and OCT-CFT, reversibility of functional loss and therapy saturation of injections.
Results: 5.8 injections/year resulted in a gain of 6.9 letters until the end of loading phase and 5.0 letters after 12 months. Three different responder-types could be classified. The over-all and responder classified analysis indicated that functional loss followed an increase in OCT-CFT of 23 to 33 µm with a latency of 1–2 months. The quantity of permanent visual loss after deterioration significantly increased with the temporal reference point and the number of letters previously lost. Visual rehabilitation presented a two peak distribution (one peak around no rehabilitation, second around complete restoration). In eyes with persistent or recurrent disease a saturation point of 10.2 injections was calculated. Therapy saturation for the whole group was evaluated at 8.4 injections.
Conclusions: The following information extracted from the analyses may be helpful for the design of future therapy concepts: 1. A theoretical saturation point of therapy was calculated at 8.4 injections within the first year. 2. Relatively small increases in mean OCT-CFT are an early and sensitive indicator of functional deterioration. 3. Use of low grade and acute functional deterioration as an indicator seems to provide advantages compared to the EMEA-critreria for re-injection.