Reasonable watchful waiting for patients with diabetic macular edema and good vision

People with good vision despite diabetic macular edema involved in the center may safely give up the immediate treatment of their ocular problem, provided they are closely monitored, and treatment begins promptly if vision deteriorates, according to the results of clinical trials. The findings are published online today in the Journal of the American Medical Association.

The study was conducted by DRCR Retina Network, a multicenter clinical research network funded by the National Eye Institute, part of the National Institutes of Health (NIH).

Diabetic macular edema is the most common cause of vision loss in people with diabetic eye disease in the United States. Diabetes can lead to leakage in the blood vessels of the retina – the photosensitive tissue located at the back of the eye. Diabetic macular edema is the result of a build-up of fluid in the central area of ​​the retina, called macula, which is important for clear vision. Swelling of the macula can alter the vision needed for reading and driving.

Evidence from this study should help physicians and patients navigate a common conundrum in ophthalmology: Treating diabetic macular edema in people who still have good vision too soon can expose them to unnecessary costs and risks of treatment. Other patients who receive treatment too late may lose vision permanently.

"We now know that in patients with good vision and diabetic macular edema, similar to those included in this trial, it is acceptable to follow patients closely and start treatment only if their vision begins to show signs. of decline, "said study chief investigator Carl W. Baker, MD, ophthalmologist at the Paducah Retinal Center (Kentucky).

Glycemic control in diabetic patients helps prevent eye diseases related to diabetes. In addition, treatments directly targeting diabetic macular edema – laser photocoagulation and vascular endothelial growth factor (anti-VEGF) agents injections – reduce or eliminate abnormal leakage from blood vessels.

The trial included 702 participants with diabetic macular edema and vision of 20/25 or more, which is considered normal or near normal vision. At the beginning of the study, the participants were randomly badigned to one of the following three management strategies for one of their eyes: 1) inject in the eye the following. aflibercept, anti-VEGF agent (EYLEA®) as often as every four weeks, 2) perform laser photocoagulation, or 3) perform participant observation.

During the two-year study, the detection of a loss of visual acuity prompted to administer aflibercept injections to people with laser or observation groups. Aflibercept injections were therefore required in 25% of the laser group and 34% of the observation group. The eyes that started the aflibercept injections in the laser and observation groups required a total number of injections similar to that of the group initially badigned to aflibercept.

The researchers checked the participants' visual acuity throughout the study during regular follow-up visits to specialized retinal clinics. The researchers measured visual acuity in the laser and observation groups eight and 16 weeks after the start of the study, and then every 16 weeks, unless their visual acuity deteriorated.

At the end of two years, the percentage of participants whose eye to study reached a predefined threshold of visual acuity loss – one or more lines of the eye diagram – did not differ from those in the study. one group on the other: 16% of the aflibercept group, 17% of the laser group. group and 19% in the observation group. The average visual acuity, which was 20/20 at the start of the study, remained 20/20 in all three groups at two years.

"From what we have seen in previous longer-term studies of people suffering from diabetic macular edema, the results of visual acuity observed at the end of this study of two years will likely be retained if patients continue regular follow-up and treatment as needed in subsequent years, "said Jennifer K. Sun, MD, MPH, co-chair of DRCR's Retina Network, badociate professor of ophthalmology at Joslin Diabetes Center. from Harvard Medical School.

"Future technologies could help better identify people who could benefit from early treatment, before diabetic macular edema affects vision," said director of the study coordination center , Adam R. Glbadman, MS, Jaeb Center for Health Research in Tampa. "But for now, close monitoring of diabetic macular edema in patients with good vision is an appropriate initial strategy, provided that they are followed closely and treated thereafter if the vision is deteriorating. "

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The clinical trial of 91 centers was funded by grants NEI EY14231, EY23207 and by the National Institute of Diabetes and Digestive and Kidney Diseases, which is also part of the NIH. ClinicalTrials.gov ID: NCT01909791

For more information on diabetic macular edema, visit https: //nei.nih.gov /health/Macular edema /fact sheet

CW Baker, Glbadman AR, Beaulieu WT, Antoszyk AN, DJ Browning, KV Chalam, Grover S, LM Jampol, Jhaveri CD, Melia M, Stockdale CR, Martin DF, Sun JK, for the DRCR Retina Network. "Effect of initial management aflibercept vs laser photocoagulation vs observation on vision loss in patients with diabetic macular edema involving the center of the macula and good visual acuity: a randomized clinical trial". Posted online April 29, 2019, JAMA.

Conflict Information:

A complete list of the financial information of all the DRCR Retina network investigators is available at the following address: http: // www.DRCR.net. Regeneron Pharmaceuticals, Inc. has provided aflibercept for the study and funds to DRCR Retina Network to cover the costs of the clinical site of the study. According to DRCR Retina network sector collaboration guidelines (available at http: // www.DRCR.net), the DRCR Retina network fully controlled protocol design, data ownership, and all editorial content of protocol-related presentations and publications.

NEI directs federal government research on the visual system and eye diseases. NEI supports basic and clinical science programs aimed at developing eye-saving treatments and meeting the special needs of the visually impaired. For more information, visit https: //www.nei.nih.government.

About the National Institutes of Health (NIH): The NIH, the country's medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. NIH is the lead federal agency that leads and supports basic, clinical and translational medical research. She studies causes, treatments and cures for common and rare diseases. For more information about NIH and its programs, visit https: //www.nih.gov /.