Inside the Diabetic Retinopathy Clinical Research Network

BY VIRGINIA PICKLES, CONTRIBUTING EDITOR

Since 2002, the Diabetic Retinopathy Clinical Research (DRCR) Network has been conducting clinically relevant multicenter research studies focused on diabetes-induced retinal disorders. To date, the network has published approximately 50 papers, providing real-world guidance that clinicians have come to rely upon.

“The DRCR Network provides the framework for collecting data on hundreds of patients with similar degrees of diabetic retinopathy, enabling clinicians across the country to study treatments in a manner that would not be possible in a single private office or a single university,” says Harry W. Flynn, Jr., MD, professor and J. Donald M. Gass Chair of Ophthalmology at Bascom Palmer Eye Institute in Miami and a member of the DRCR Network Data and Safety Monitoring Committee. “Using similar entry criteria and similar data-collection forms, DRCR Network researchers can assess a population of patients and their responses to treatment in a relatively short time.”

The studies conducted by the DRCR Network represent the collaborative efforts of more than 400 U.S. physicians at more than 115 participating sites. Studies are funded primarily by the National Eye Institute, although some support may be provided by the private sector. For example, study drugs used in some protocols were donated by pharmaceutical companies.

Three core centers support the network’s overall operation and leadership: the Jaeb Center in Tampa, Fla. (the coordinating center), the National Eye Institute in Bethesda, Md., and the office of the chairman, Lee M. Jampol, MD. Various subcommittees ensure the consistency, safety and integrity of the trials and publications. The protocols are suggested by the investigators themselves. “Let’s say a promising new drug has come on the market and has shown some benefit in case series, but its overall benefit with 1 or 2 years of follow-up is unproven,” Dr. Flynn explains. “The Protocol Committee submits its recommendation to the Executive Committee, which discusses the pros and cons of new approaches. If they approve it, the Protocol Committee develops a full study protocol. After approval by the Data and Safety Monitoring Committee, the protocol can be put into action, and patients can be recruited for the DRCR trial.”

Table 1 recaps some of the key DRCR Network studies published over the last several years, reflecting the rapid evolution of treatments for diabetic eye diseases. Clinicians are anxiously awaiting 2-year data from Protocol T to learn if the results obtained at 1 year are maintained. One recently approved trial is Protocol V, which is currently recruiting participants to determine if patients with center-involving diabetic macular edema who have good visual acuity should be treated with laser or anti-VEGF therapy or observed.

“Clinical trials performed by the DRCR Network have been enormously successful,” Dr. Flynn says. “Many of them have altered our standard of care for diabetic eye diseases.” ❖