Yes, so many variables, there always are. Patient factors and treatment factors. If you want to design a controlled prospective trial to examine all of them then the numbers start to escalate very quickly. Two arms for Lucentis/OPT302 (one arm treatment naive), two arms for Eylea (one treatment Naive) plus the control arms for each, adequate numbers for subgroups such as duration of treatment prior to the trial, different severity of disease...
1200 patients followed for a 12 months...
A costly definitive trial that will take a long time, but reveal a lot. Or try to get a smaller focused trial over the line with the FDA and some commercial approval while leaving some doubts in the minds of ophalmologists and leave it to further small trials to try and sort out the details.
Yes, so many variables, there always are. Patient factors and...
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