People with good vision despite having centre-involved diabetic macular oedema can safely forego immediate treatment of their eye condition as long as they are closely monitored, and treatment begins promptly if vision worsens, according to a study published in JAMA.
The evidence from this study should help physicians and patients navigate a common conundrum in ophthalmology: treating diabetic macular oedema in people who still have good vision too soon may subject them to unnecessary costs and risks associated with treatment. Other patients who get treatment too late might risk losing vision permanently.
“We now know that in patients with good vision and diabetic macular oedema, similar to those enrolled in this trial, it’s an acceptable strategy to closely monitor patients, and initiate treatment only if their vision starts to show signs of decline,” said Carl W. Baker, MD, Paducah (Kentucky) Retinal Center, Paducah, Kentucky.
The trial included 702 patients with diabetic macular oedema and 20/25 vision or better. At the start of the study, participants were randomised to aflibercept injections as frequently as every 4 weeks, laser photocoagulation, or to watchful waiting.
During the 2-year study, the detection of visual acuity loss prompted aflibercept injections to be given to the people in the laser or observation groups. Aflibercept injections were thus required among 25% of the patients in the laser group and 34% of the observation group. Eyes that started aflibercept injections in the laser and observation groups required a similar number of injections overall compared with the group initially assigned to aflibercept.
Visual acuity was assessed throughout the study at regular follow-up visits in retina specialty clinics. Visual acuity was measured in the laser and observation groups at 8 and 16 weeks after study entry, and then every 16 weeks unless their visual acuity worsened.
After 2 years, the percentage of participants whose study eye met a pre-specified threshold for visual acuity loss (≥1 lines on an eye chart) did not differ among the aflibercept group (16%), the laser group (17%), and the observation group (19%). The average visual acuity, which was 20/20 at baseline, remained 20/20 in all 3 groups at 2 years.
“Based on what we’ve seen in previous, longer-term studies of people with diabetic macular oedema, the visual acuity outcomes observed at the end of this 2-year study are likely to be maintained if patients continue regular follow-up and treatment as needed over subsequent years,” said Jennifer K. Sun, MD, Joslin Diabetes Center, and Harvard Medical School, Boston, Massachusetts.
“Close monitoring of diabetic macular oedema in patients with good vision is an appropriate initial strategy as long as they are closely followed and subsequently treated if vision worsens,” added Adam R. Glassman, Jaeb Center for Health Research, Tampa, Florida.
SOURCE: National Institutes of Health