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The use of aflibercept led to greater improvement in macular perfusion status in a phase III trial with DME patients. Those with baseline nonperfusion tended to have more advanced disease.
By Vanessa Caceres
Diabetic macular edema (DME) patients with baseline macular nonperfusion had more advanced disease. When comparing treatments in those patients, aflibercept (Eylea, Regeneron Pharmaceuticals) led to a greater improvement in macular perfusion status as well as visual and anatomic improvement by week 100.
The post-hoc analysis came from the VIVID and VISTA trials, which were 2 parallel, phase III, randomized, multicenter, double-masked trials in patients with clinically significant DME, according to Dilsher S. Dhoot, MD, Retina Consultants, Santa Barbara, CA.
Patients had central involvement and an ETDRS best-corrected visual acuity of 20/40 to 20/320. Patients were randomized to receive 1 of 2 different dosings schedules of aflibercept or they were part of a control arm receiving a laser treatment. The study continued through week 148.
The results presented by Dr. Dhoot focused on subretinal changes through week 100, as well as visual outcomes with and without macular perfusion.
“We evaluated visual and anatomic outcomes among patients with and without macular nonperfusion and considered if they were impacted by a change in the macular perfusion,” Dr. Dhoot said.
The subanalysis included 452 patients from the VISTA trial. Patients with missing or ungradable perfusion data or those receiving rescue medications were not included.
Patients had fluorescein angiograms performed during the VISTA trial at baseline and at weeks 24, 52, 72, and 100. Angiograms were graded by masked independent graders at a reading center, and the angiograms were divided into quadrants at the intersecting optic nerve head.
“A quadrant was determined to be nonperfused with any presence of nonperfusion,” Dr. Dhoot said.
When analyzing all 4 quadrants, 60% to 70% had nonperfusion, or ischemia, as graded by the reading center. In the group receiving laser treatment, 15% or less had improvement, compared with 45% and 40% in the aflibercept groups.
“On the flip side, regarding the proportion of patients with worsening perfusion status at week 100, 25% had worsening [in the laser group] compared to 9% in the aflibercept groups,” Dr. Dhoot said. “There were significantly improved results with aflibercept.”
When focusing on the quadrant that encompassed the macula and asking how baseline macular ischemia fared with visual acuity and anatomic outcomes, 66% to 75% of patients had baseline ischemia. Patients with baseline ischemia had severe disease as marked by worse vision by about 5 letters and increased central retinal thickness.
“The baseline distribution of the diabetic retinopathy severity score also was worse in patients with baseline ischemia,” Dr. Dhoot added.
When patients in the subanalysis had reperfusion or changes in their status, the proportion with improvement was about 50%.
“In terms of visual acuity, patients had a similar visual acuity whether or not they had ischemia improvement,” he said.
Dilsher S. Dhoot, MD
This article was adapted from a presentation that Dr. Dhoot delivered at the 2017 American Academy of Ophthalmology meeting. Dr. Dhoot is a consultant for Alimera Sciences, Allergan, Genentech, Notal Vision, Regeneron, and Santen.