TREVISO, Italy — Management of diabetic retinopathy requires flexible, personalized approaches, which new advances are making possible.
“Diabetic patients present a variety of phenotypes, different VA, degrees of retinopathy and edema,” Anat Loewenstein, MD, MHA, said at the Retina 2020: New Trends meeting. “Advances in imaging technologies, rigorous trials and consensus guidelines provide the basis on which to plan our treatment approach.”
Diabetic retinopathy may require only close surveillance, but the PANORAMA trial showed that treatment with Eylea (aflibercept, Regeneron), in absence of macular edema, resulted in improvement in diabetic retinopathy severity and fewer complications in some patients. Conversely, there is now consensus that simple observation or subthreshold laser therapy may be considered for non-center-involved macular edema.
“DRCR.net Protocol V results suggest that very mild central edema with good vision can also be managed by observation,” Loewenstein said.
Anti-VEGFs are first-line treatment for severe edema. Protocol T showed excellent results with all drugs, with some advantage for aflibercept in the first year. Corticosteroids can be used upfront if anti-VEGFs are contraindicated, with fewer concerns in pseudophakic patients.
“Several studies, the most important of which was the MEAD trial, showed excellent results with Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan), with fewer injections as compared with anti-VEGFs. Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences), on the other hand, showed higher benefits in chronic disease,” Loewenstein said.
In non-responders, switching between anti-VEGFs or from anti-VEGF to Ozurdex is usually beneficial. Studies have found that subretinal fluid is a biomarker of a better response to Ozurdex.
“Biomarkers are increasingly becoming a target in research, and we might be able to decide on treatment according to biomarkers such as subretinal fluid,” Loewenstein said.
She said that a combination of pharmacological agents is used quite often in Europe but was not supported by Protocol U. In Protocol T, 40% to 60% of patients needed additional laser treatment, but in the follow-up period rather than upfront.
Novel therapies address the issue of treatment burden by aiming at prolonged efficacy. Faricimab (Genentech/Roche) showed efficacy in diabetic macular edema in the phase 2 BOULEVARD study. Brolucizumab (Novartis) and abicipar pegol (Allergan) were tested for age-related macular degeneration, but studies for DME are also in the pipeline.
Telemedicine, hand-held technology and home monitoring systems are addressing the still unmet need of detecting the disease earlier and in a wider population, including remote areas with the highest prevalence of blindness.
In April 2018, the FDA approved IDx-DR (IDx), the first telemedicine test for detection of greater than mild diabetic retinopathy, and in 2019 this technology was made widely available in clinics. Inexpensive and easy-to-use smartphone-based fundus camera systems have been developed with the simple addition of lenses and adjustable supports.
“Another idea is the Notal Vision Home OCT, very easy to use by the patients at home. Via web transfer, images are viewable by the physician, and an AI algorithm analyzes images for fluid,” Loewenstein said.
The Home OCT was granted breakthrough device designation by the FDA and was assigned a reimbursement code in the U.S. on Jan. 8.
“This is an important step forward towards more efficient monitoring of patients and individualized treatment,” Loewenstein said. – by Michela Cimberle
Loewenstein A. Pharmacological association and shifting in the treatment of diabetic macular edema. Presented at: Retina 2020: New Trends; Jan. 24-25, 2020; Treviso, Italy.
Disclosure: Loewenstein reports she is a consultant for Alimera, Allergan, Bayer Healthcare, ForSight Labs, Notal Vision and Novartis.