sham controls make for a better trial, double blinding it as the clinicians and the patients dont know who is really getting treated. Given some of the comments I’ve read about patients getting better at some of the tests it might give better insight into who is getting better vision, ie which group. Given that they are getting eye injections this is quite a process. It is posssible PYC didn’t think they would get approval to inject eyes with no drug, just saline or similar.
Ann: FDA Alignment on Registrational Trial Design RP11 Program, page-8
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