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F. K. Sutter, M. M. Kurz-Levin; Towards an Optimized Treatment Scheme of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration: Subanalysis of Clinical Trial Data and Clinical Routine Use. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2884.
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A comparative analysis of subsets of data from Phase III trials (ANCHOR & MARINA) and data from clinical routine with a particular emphasis on the loading phase of ranibizumab treatment.
Data from MARINA (minimally classic or occult lesions (n=716) and ANCHOR (predominantly classic lesions (n=423) both involving monthly intravitreal injections of 0.5mg ranibizumab for 2 years were subanalysed regarding initial changes of visual acuity (VA). Data from these clinical trials were compared to 1 year data from routine treatment of wet AMD as derived from patients (n= 435) from the University Eye Clinic in Zurich.
In the two Phase III trials, the greatest gain in mean VA was seen after the first injection. This improvement generally increased only slightly with the second and third injections, but resulted in a stabilization of the VA gain. After three monthly injections of ranibizumab, patients treated with 0.5mg ranibizumab in the MARINA trial had a mean increase from baseline of 6.3 letters, and patients in the ANCHOR trial had a mean increase of 10.3 letters.*p<0.05; p<0.01; p<0.001
We will report further subanalysis of MARINA and ANCHOR data and compare the results to data derived from clinical routine. This will facilitate the development of an optimized treatment scheme for wet AMD, considering optimal visual results, patient comfort and clinical workload. As the majority of patients in the ANCHOR and MARINA trials experienced most VA gain during the first three monthly injections, a standardized treatment initiation with three monthly doses of ranibizumab appears an optimal and efficient regimen for treating wet AMD.
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