September 19, 2016

FDA clinical trials principally are developed to determine if a drug or device can demonstrate safety and efficacy. However, they also provide a potential treatment avenue for patients with sight-threatening diseases at times when no other options may exist.

The website is an invaluable resource for clinicians who are interested in learning more about recently completed and ongoing studies of novel drugs, devices and other treatment options used to manage a host of disease states. Many of the ongoing studies listed are on the site are actively recruiting and enrolling participants. Having an opportunity to test the viability of emerging treatment options can provide hope patients with rare or recalcitrant conditions.

One study of particular interest outlined on involves a potential treatment option for non-arteritic anterior ischemic optic neuropathy (NAAION).1 The researchers are evaluating visual recovery following injection of a novel agent, QPI-1007. Currently, there is no known treatment for NAAION. The researchers are actively seeking study participants between the ages of 50 and 80 who have been diagnosed with NAAION within the last 14 days. The website also shows study sites that are currently enrolling patients.

Of course, there are multiple risks associated with clinical trial enrollment. The most obvious concern for patients is that the drugs or devices being evaluated typically are not yet FDA approved for the indication in question. Further, there’s usually a chance that certain patients will receive a placebo. For example, there is a one in five chance of patients receiving sham injections in the aforementioned NAAION study. Finally, clinical trials often necessitate a significant time commitment from enrolled participants, as well as require the reading and signing of an extensive volume of legal paperwork.

Nonetheless, such ongoing clinical trials for sight-threatening ocular conditions without current treatment options can provide affected patients with hope for a potential cure.

1. Klier S. Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Sub-jects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). Identifier: NCT02341560. Available at: .

"To know what you prefer instead of humbly saying Amen to what the world tells you ought to prefer is to have kept your soul alive"
    –Robert Louis Stevenson

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