Wet AMD Treatment Outcomes Look Misleadingly Better in Clinical Trials

AUGUST 10, 2016
Caitlyn Fitzpatrick
In clinical trials, patients typical gain eight letters. However, the patients in the six-month group lost less than one letter. Patients who dropped out at six months did worse than those who dropped out at 12 months. This trend continued as those who dropped out at 12 months did worse than those who dropped out at 24 months.

“Real world wet AMD patients generally lose vision except for those with poor baseline VA,” Ciulla explained. Patients who started with a baseline worse than 20/70 ended up losing by 24 months.

Compared to clinical trials, VA outcomes are worse and there are fewer injections done in the real world. Ciulla said that patients lost to follow-up are likely doing poorly.

The Horizon study was a clinical trial that showed over four years, there was an average two-letter gain. However, this trial was missing 32% of data. “If there was a way to account for this data, the outcomes would have been worse,” Ciulla said, noting that he was a researcher on the study. The CATT study was another example of one that showed substantial results – a three-letter loss after five years – but it was missing 42% of data.

The implication here is that real world outcomes are substantially different than randomized controlled trials. Also, clinicians should know as much information behind a trial as possible before jumping to conclusions – all the while data is missing.

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