Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.
Laser treatment alone has been the standard care for the past 25 years. But nearly 50 percent of patients who received this new treatment experienced substantial visual improvement after one year, compared with 28 percent who received the standard laser treatment. The study involved 52 clinical sites within the Diabetic Retinopathy Clinical Research Network (DRCR.net), supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.
"These results indicate a treatment breakthrough for saving the vision of people with diabetic macular edema," said Neil M. Bressler, M.D., chair of the DRCR.net and chief of the Retina Division at the Wilmer Eye Institute, Johns Hopkins University, Md. "Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for patients with characteristics similar to those in this clinical trial."
Diabetic retinopathy is the most common cause of vision loss in working-age Americans. This condition damages the small blood vessels in the eye's light-sensitive retinal tissue. When these damaged blood vessels begin to leak fluid near the center of the retina, known as the macula, macular edema occurs. The macula provides detailed central vision used for activities such as reading, driving, and distinguishing faces. In macular edema the retinal tissue swells, which can lead to vision loss if left untreated.
Laser treatment of the retina has been the standard care for diabetic macular edema since an NEI-supported study in 1985 showed it to be beneficial. However, recent small short-term studies have revealed the visual benefits of eye injections of medications that block a chemical signal that stimulates blood vessel growth, known as vascular endothelial growth factor (VEGF). These studies have indicated that repeated doses of anti-VEGF medications, such as ranibizumab, may prevent blood vessels from leaking fluid and causing macular edema. The DRCR.net study, published online April 27 in Ophthalmology, confirms preliminary results and provides evidence of the treatment's effectiveness in combination with laser therapy through at least one year of follow up.
"This comparative-effectiveness study demonstrated that a new treatment can protect and, in many cases, improve the vision of people with diabetic macular edema," said NEI Director Paul A. Sieving, M.D., Ph.D.
The current study included a total of 854 eyes of 691 people, who had one or both eyes treated. Participants, who were on average in their early 60s, were diagnosed with type 1 or 2 diabetes and macular edema. They were randomly assigned to one of four study groups: sham injections plus prompt laser treatment within one week; ranibizumab injections plus prompt laser treatment; ranibizumab plus deferred laser treatment after six months or more; or injections of corticosteroid medication known as triamcinolone (Trivaris) plus prompt laser treatment.
Ranibizumab injections could be given as often as every four weeks, and triamcinolone injections or laser treatments could be given as often as every 16 weeks. In general, treatment was continued until a participant's vision or retinal thickness returned to normal, or additional treatment did not improve vision or retinal swelling.
After one year, nearly 50 percent of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. People could read at least two additional lines on an eye chart with the treated eye, or letters that were at least one-third smaller than they could read before the study treatment. Fewer than 5 percent of eyes in these groups experienced a visual loss of two or more lines. The results were similar whether patients received prompt or deferred laser treatment with the ranibizumab injections.
In contrast, about 30 percent of eyes that received laser treatment alone or triamcinolone plus laser showed a visual improvement of two or more lines on an eye chart, while 13 to 14 percent of eyes in these groups had a visual loss of two or more lines.
Although participants in all three injection groups had a greater decrease in retinal thickness after one year than with laser treatment alone, patients who received triamcinolone injections had greater complication rates. About 30 percent of people in the triamcinolone group developed high eye pressure that required medications, and about 60 percent developed cataracts that required surgery.
Few participants who received eye injections of ranibizumab had eye-related complications, such as an infection inside the eye likely caused by the injections, or worsening of a retinal detachment that existed prior to beginning treatment. The study found that eye injections of ranibizumab were not associated with any serious risks such as heart attack or stroke. DRCR.net researchers will continue to monitor the study participants for at least three years to obtain additional information about the safety and effectiveness of these macular edema treatments.
Find more information about this clinical trial (NCT00444600) at www.clinicaltrials.gov.
The National Eye Institute, part of the National Institutes of Health, 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 www.nei.nih.gov.
The National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.
The National Institutes of Health (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. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.
National Eye Institute | EurekAlert!
Rutgers-led innovation could spur faster, cheaper, nano-based manufacturing
14.02.2018 | Rutgers University
New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg
Satellites in near-Earth orbit are at risk due to the steady increase in space debris. But their mission in the areas of telecommunications, navigation or weather forecasts is essential for society. Fraunhofer FHR therefore develops radar-based systems which allow the detection, tracking and cataloging of even the smallest particles of debris. Satellite operators who have access to our data are in a better position to plan evasive maneuvers and prevent destructive collisions. From April, 25-29 2018, Fraunhofer FHR and its partners will exhibit the complementary radar systems TIRA and GESTRA as well as the latest radar techniques for space observation across three stands at the ILA Berlin.
The "traffic situation" in space is very tense: the Earth is currently being orbited not only by countless satellites but also by a large volume of space...
An international team of researchers has discovered a new anti-cancer protein. The protein, called LHPP, prevents the uncontrolled proliferation of cancer cells in the liver. The researchers led by Prof. Michael N. Hall from the Biozentrum, University of Basel, report in “Nature” that LHPP can also serve as a biomarker for the diagnosis and prognosis of liver cancer.
The incidence of liver cancer, also known as hepatocellular carcinoma, is steadily increasing. In the last twenty years, the number of cases has almost doubled...
In just a few weeks from now, the Chinese space station Tiangong-1 will re-enter the Earth's atmosphere where it will to a large extent burn up. It is possible that some debris will reach the Earth's surface. Tiangong-1 is orbiting the Earth uncontrolled at a speed of approx. 29,000 km/h.Currently the prognosis relating to the time of impact currently lies within a window of several days. The scientists at Fraunhofer FHR have already been monitoring Tiangong-1 for a number of weeks with their TIRA system, one of the most powerful space observation radars in the world, with a view to supporting the German Space Situational Awareness Center and the ESA with their re-entry forecasts.
Following the loss of radio contact with Tiangong-1 in 2016 and due to the low orbital height, it is now inevitable that the Chinese space station will...
Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP, provider of research and development services for OLED lighting solutions, announces the founding of the “OLED Licht Forum” and presents latest OLED design and lighting solutions during light+building, from March 18th – 23rd, 2018 in Frankfurt a.M./Germany, at booth no. F91 in Hall 4.0.
They are united in their passion for OLED (organic light emitting diodes) lighting with all of its unique facets and application possibilities. Thus experts in...
A new scenario seeking to explain how Mars' putative oceans came and went over the last 4 billion years implies that the oceans formed several hundred million...
23.03.2018 | Event News
19.03.2018 | Event News
16.03.2018 | Event News
23.03.2018 | Materials Sciences
23.03.2018 | Agricultural and Forestry Science
23.03.2018 | Physics and Astronomy