New Treatment Option Announced for Diabetic Retinopathy

webguru Tips for Families

Diabetes patients with proliferative diabetic retinopathy, a common eye disorder among people with diabetes, have a new treatment option that may improve their vision and potentially prevent further diabetic retinopathy complications.

The National Eye Institute announced today that the drug Lucentis® is highly effective in treating proliferative diabetic retinopathy, becoming the first major therapy advance for the eye disease in nearly 40 years. Lucentis® was compared with a type of laser therapy called panretinal or scatter photocoagulation, which has been the gold standard for treatment of proliferative diabetic retinopathy since the 1970s.

The clinical trial was conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), which is funded by the National Eye Institute. Retina Consultants of Southwest Florida is one of the 55 clinical trial sites throughout the U.S., and the only site in Lee, Collier and Charlotte counties.

Patients from throughout Lee, Collier and Charlotte counties participated in the clinical trial, according to Dr. Thomas Ghuman, retinal specialist with Retina Consultants of Southwest Florida and principal investigator with DRCR.

“The latest results from the DRCR Network have again demonstrated the versatility of anti-vegf medications. We are pleased to be able to offer another treatment option to patients that may improve their overall results,” Dr. Ghuman said.

The results were published online today in the Journal of the American Medical Association.

Treating abnormal retinal blood vessels with laser therapy became the standard treatment for proliferative diabetic retinopathy after the NEI announced results of the Diabetic Retinopathy Study in 1976. Although laser therapy effectively preserves central vision, it can damage night and side vision; so, researchers have sought therapies that work as well or better than laser but without such side effects.

A complication of diabetes, diabetic retinopathy can damage blood vessels in the light-sensitive retina in the back of the eye. As the disease worsens, blood vessels may swell, become distorted and lose their ability to function properly. Diabetic retinopathy becomes proliferative when lack of blood flow in the retina increases production of a substance called vascular endothelial growth factor, which can stimulate the growth of new, abnormal blood vessels. These new vessels are prone to bleeding into the center of the eye, often requiring a surgical procedure called a vitrectomy to clear the blood. The abnormal blood vessels can also cause scarring and retinal detachment. Lucentis is among several drugs that block the effects of vascular endothelial growth factor.

About 7.7 million U.S. residents have diabetic retinopathy, a leading cause of blindness among working-age Americans. Among these, about 1.5 percent have PDR.

The DRCR.net enrolled 305 participants (394 eyes) with proliferative diabetic retinopathy in one or both eyes at 55 clinical sites across the country. Eyes were assigned randomly to treatment with Lucentis or laser. For participants who enrolled both eyes in the study, one eye was assigned to the laser group and the other was assigned to the Lucentis group. About half of the eyes assigned to the laser group required more than one round of laser treatment. In the other group, Lucentis (0.5 mg/0.05 ml) was given via injections into the eye once per month for three consecutive months, and then as needed until the disease resolved or stabilized.

At two years, vision in the Lucentis group improved by about half a line on an eye chart compared with virtually no change in the laser group. There was little change in side vision with injection (average worsening of 23 decibels) but a substantial loss of side vision with laser (average worsening of 422 decibels). The vitrectomy rate was lower in the Lucentis group (8 of 191 eyes) than in the laser group (30 of 203 eyes).

Rates of serious systemic adverse events, including cardiac arrest and stroke, were similar between the two groups. One patient in the Lucentis group developed endophthalmitis, an infection in the eye. Other side effects were low, with little difference between treatment groups.

“Lucentis should be considered a viable treatment option for people with proliferative diabetic retinopathy, especially for individuals needing anti- vascular endothelial growth factor for diabetic macular edema,” said Jeffrey G. Gross, M.D., of the Carolina Retina Center in Columbia, S.C., who chaired the study. Dr. Gross presented results today at the annual meeting of the American Academy of Ophthalmology in Las Vegas.

In addition to treating proliferative diabetic retinopathy, the report suggests Lucentis may even help prevent diabetic macular edema from occurring. Among people without diabetic macular edema at the start of the study, only 9 percent of Lucentis-treated eyes developed diabetic macular edema during the study, compared with 28 percent in the laser group. The DRCR.net will continue to follow patients in this study for a total of five years.

The DRCR.net is dedicated to facilitating multicenter clinical research of diabetic eye disease. The network formed in 2002 and comprises more than 350 physicians practicing at more than 140 clinical sites across the country. For more information, visit the DRCR.net website at http://drcrnet.jaeb.org/.

Additional Resources
The study was funded by NEI grants EY14231, EY23207, EY18817.
Lucentis was provided by Genentech. Additional research funding for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, also a part of the NIH.
The study is registered as NCT01489189 at ClinicalTrials.gov.
The NEI provides information about diabetic eye disease at http://www.nei.nih.gov/health/diabetic/.
Information about diabetes is available through the National Diabetes Education Program, www.ndep.nih.gov/.
View an NEI video about the study at https://youtu.be/jPoCIa0_1po.

About Retina Consultants of Southwest Florida

Retina Consultants of Southwest Florida is the most experienced team of retina specialists in Southwest Florida with combined experience of more than 125 years. Offices are conveniently located in Fort Myers, Cape Coral, Bonita Springs, Naples and Port Charlotte.

Doctors with Retina Consultants of Southwest Florida are Fellows of the American College of Surgeons, members of the American Society of Retina Specialists, American Academy of Ophthalmology, The Schepens Eye Research Institute/Massachusetts Eye and Ear, an affiliate of Harvard Medical School, and the American Medical Association.
Retina Consultants of Southwest Florida offers all FDA-approved therapies for retina eye disease and is a leader in clinical research through the National Ophthalmic Research Institute (NORI), including clinical trials funded by the National Eye Institute, Massachusetts Eye and Ear, an affiliate of Harvard Medical School, and other public and private medical research foundations.

About the National Eye Institute

NEI leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs that result in the development of sight-saving treatments. For more information, visit https://www.nei.nih.gov.
The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, visit http://www.niddk.nih.gov.

About the National Institutes of Health (NIH)

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.