Thanks to an aging world population and increase in comorbid diseases, ophthalmic disorders are on the rise. Not only do they present a huge burden to society, the associated healthcare costs are significant. Which is why the search for new treatments is more important than ever. However, the very nature of ophthalmic diseases means that they are particularly difficult to research. The eye has a complex anatomy that can be affected by a wide range of disorders. For example, diabetes and some CNS conditions can affect ocular health, which means that patients’ eligibility for trials may be compromised by contraindicated medications. Sight-threatening conditions are diagnosed and treated very quickly, so finding and recruiting treatment-naïve patients can be extremely difficult.
What’s more, investigative sites for ophthalmology trials have to offer a wide range of specialized equipment (for example, OCT, fundus photography, fluorescein angiography, microperimetry, fundus autofluorescence and ETDRS BCVA assessment) as well as highly trained people to operate it. In addition, all imaging techniques and equipment has to be certified by central reading centers.
So what does this mean for companies looking to research new treatments for ophthalmic diseases? A patient population that’s difficult to recruit, combined with increasingly focused inclusion/exclusion criteria and the need for in-depth ophthalmic expertise, means that you need a CRO with real therapeutic alignment, long-standing site relationships, disease-specific experience and appreciation of the logistical set-up and conduct of ophthalmology studies.
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Raleigh, NC 27604-1547