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Theodora Gkika, Shaista Giny, Andrej Kidess, Helen Palmer, Alastair K Denniston; Uveitis Clinical Trials Analysis 2000-2015. Invest. Ophthalmol. Vis. Sci. 2017;58(8):519.
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© ARVO (1962-2015); The Authors (2016-present)
To analyse the trends in the subject and design of clinical trials in uveitis from 2000-2015.
We conducted a systemic registry review of the NIH clinical trials registry (clinical trials.gov) for all trials categorised under uveitis . Data analysed included study design, type of uveitis included, source of funding; for interventional studies the phase, endpoint classification and type of intervention were also noted.
A total of 216 studies were identified increasing from an average of 2 studies per year for 2000-2003 to 19 studies per year for 2012-2015. During the study period the proportion of studies that were interventional remained fairly constant at around 70%. The proportion of trials receiving industry funding increased from 14% (2000-2003) to 47% (2012-2015). Studies of intermediate/posterior/panuveitis (n=33) were almost twice as common as anterior uveitis (n=18), although most studies either specifed by syndrome (n=54) or did not restrict by anatomical subtype (n=127). Of the 157 interventional trials, the intervention was a drug in 146, a device in 6, and surgery/ other in 5. The number of phase 2/3 or later phase trials increased from <1/yr (2000-2003) to 7/yr (2012-2015), with randomised controlled trials increasing from <1/yr (2000-2003) to 5/yr (2012-2015).
There has been an increase in research investment in uveitis over the last 16 years, with greater engagement from industry and improved progression through the drug-development pipeline to later phase trials, and which is now providing benefit to patients through regulatory approval of therapeutics such as Ozurdex and adalimumab.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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