Article
Ranibizumab – transferable from multicenter study to clinical practice?
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Published: | June 29, 2009 |
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Background: In several multicenter trials Ranibizumab is established as effective therapy in wet AMD and was imbursed in EBM since January 2007. In health services research it is questioned whether results of multicenter trials can be maintained in clinical practice.
Methods: Retrospektive data analysis of 194 patients with wet AMD treated exclusively with Ranibizumab according to the guidelines of the DOG. Visual acuity development was compared to the multicenter trials MARINA, ANCHOR and PIER and evaluated by t-test.
Results: On average 3.4 injections (min/max 1/14) were administered. After treatment (on average 4.8months) improvement in visual acuity (VA) was 5.5 letters (MARINA 6.6 (p= 0.5), ANCHOR 11.3 letters (p<0.05), PIER loss of –0.2 letters (p<0.05)). 60.8% of our patients gained VA (ANCHOR 77.7%), out of these 38.7% >15 letters (ANCHOR 40.3%, MARINA 33.8%, PIER 13.1%) and 17.5% >30 letters (ANCHOR 12.2%) (all p<0.05). Visual impairment occured in 36.1% of our patients, out of these <15 letters in 66% (ANCHOR 96.4%, MARINA 94.6%, PIER 90.2%), >30 letters in 11.3 % (ANCHOR 0%, MARINA 1.2%) (all p<0.05).
Conclusions: Ranibizumab revealed in clinical practice a comparable gain in VA compaired to MARINA-trial results with monthly injections, is worse than ANCHOR (with PDT) and better than PIER (quarterly injections after uploading). Thus, for Ranibizumab evidenced based data could be transfered in health services research.