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ASCRS Research Council aims to mirror success of DRCR.net
DRCR.net has featured successful collaboration among national institutes, industry and retina specialists.
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The Diabetic Retinopathy Clinical Research Network is a collaboration among the National Eye Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, industry and more than 400 committed retina specialists at 120 practices. The purpose of DRCR.net is to facilitate multicenter clinical research into diabetes-associated eye disease, including diabetic retinopathy, diabetic macular edema, cataract, glaucoma, vitreous hemorrhage and other eye conditions. The network is funded primarily by federal grants from the NEI along with industry. As discussed in the accompanying cover story, DRCR.net clinical trials have contributed greatly to our understanding and treatment of diabetic eye disease.
The DRCR.net was established in September 2002 and is a fantastic example of public-private collaboration. This constructive collaboration has generated nearly 30 clinical trial protocols and more than 70 peer-reviewed publications and dramatically impacted the treatment of patients worldwide. Participation is open to any retina specialist who meets the training and practice profile requirements. In addition, any retina specialist can submit a study protocol idea. The network chair is Lee Jampol, MD, of Northwestern University Feinberg School of Medicine. The coordinating center is the Jaeb Center for Health Research in Tampa, Florida, directed by Adam R. Glassman, MS, and Roy W. Beck, MD, PhD. The NEI DRCR.net Project Officer is Eleanor Schron, PhD, RN.
The knowledge gained from the multiple clinical trials and publications is nothing short of amazing. For example, we have learned that in DME focal/grid photocoagulation is superior to intravitreal triamcinolone; treatment of DME with good visual acuity is not necessary; intravitreal anti-VEGF is effective for visually significant DME; panretinal photocoagulation in one sitting is equally efficacious as when divided into four treatment sessions; OCT is a useful measure of DME and response to therapy; macular thickness measurements are variable using different OCT devices but can be normalized to one another; and subclinical DME progresses to visually significant DME in 25% to 50% of patients. The groundbreaking DRCR.net study comparing the three commercially available anti-VEGF agents confirmed comparative efficacy for all three in DME patients with vision of 20/40 or better but better outcomes with Eylea (aflibercept, Regeneron) when vision was 20/50 or worse has significantly impacted treatment decisions and reimbursement worldwide.
In my opinion, these clinical trials have been a very productive use of a portion of the $675 million appropriated to the NEI each year. Other fields including cataract, glaucoma and refractive surgery, which impact millions of patients each year in the U.S. alone, would benefit greatly from a similar collaboration among the NEI, industry and practicing ophthalmologists in academic and private settings.
The American Society of Cataract and Refractive Surgery recently created the ASCRS Research Council, whose goal is to mirror the DRCR.net collaborative model for clinical trials in anterior segment diseases and surgery. The chair of the council is Douglas J. Rhee, MD, chairman of ophthalmology at Case Western Reserve University. Jonathan Lass, MD, who has been a leader in several important clinical trials investigating critical issues in corneal transplantation and eye banking, will assist with study design, clinical trial coordination, statistical analysis and publication of outcomes.
The first topic chosen for study by the ASCRS Research Council is the comparative efficacy and safety of topical vs. intracameral antibiotics in reducing the incidence of post-cataract surgery endophthalmitis. A second study to investigate the impact of topical NSAID therapy on the near-term and long-term incidence and visual acuity impact of post-cataract surgery cystoid macular edema is also in the planning stages. A medical advisory committee of experienced surgeons is actively participating in research topic selection and study design. It will require the participation of many private and academic clinicians to answer these questions in large-scale well-designed prospective clinical trials. I encourage all of my colleagues to carefully consider participating when these important clinical trials are initiated.