Hi FreeFromStyle,reg RAP Confounding:Surprisingly, RAP was not...

Hi FreeFromStyle,

reg RAP Confounding:

Surprisingly, RAP was not evenly distributed across the predominantly classic, minimally classic and occult lesion groups. Actually, not at all. Instead, all RAP patients were found among the minimally classic and occult lesion groups. I have no idea if there is a medical explanation for this uneven distribution.

Therefore, excluding RAP detected patients from enrolling in P3 should prove extremely beneficial for maximizing the probability of statistical significance in the topline results (concentrating on the minimally classic and occult lesion groups anyway) as well as full data some further weeks down the road.

Ballpark-wise, one could even dare to separately quantify the effect of excluding both RAP detected patients (from enrolling altogether) as well as predominantly classic lesions (from topline analysis):
1. ex RAP increases BCVA by 30% (4.4 letters vs 3.4 letters)
2. ex predominantly classic increases BCVA by another(!) 30% (5.7 letters vs 4.4 letters)


reg BCVA - what does 3, 4 or 5 letter mean?

In its trials, OPT is working with a different chart to measure visual acuity at base line as well as throughout the study, that‘s the ETDRS chart. It very intuitively shows why so much importance is attributed to a 5 letter improvement and why it says „5 letters = 1 line“.

A 5 letter improvement over gold standard in wAMD is like overcoming earth‘s gravity in space travel: Beyond this point your journey (into selling the drug) becomes light and easy and without any boundaries (in potential peak sales) left...