NEW YORK (Reuters Health) – Intravitreal injections of aflibercept can reduce the severity of nonproliferative diabetic retinopathy (NPDR), according to the results of an international sham-controlled trial.
“Diabetic retinopathy is a major cause of preventable visual impairment and blindness. The PANORAMA trial demonstrates the value of early intervention towards preventing the development of clinically relevant, vision-threatening anatomic endpoints,” Dr. Charles C. Wykoff of Retina Consultants of Texas, Houston, told Reuters Health by email.
The trial involved one eye in each of 402 participants with severe NPDR. They were randomized to a control group receiving sham injections or one of two aflibercept groups.
The first group (aflibercept 2q16) received intravitreal injections of aflibercept 2 mg every 16 weeks after three initial monthly doses and one eight-week interval. The second group (aflibercept 2q8/PRN) had 2 mg injections of aflibercept every eight weeks after five initial monthly doses, with PRN dosing beginning at week 56.
At 24 weeks, a two-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS) level was observed in 157 of 269 eyes (58%) in the combined aflibercept groups versus eight of 133 eyes (6%) in the control group (P<0.001).
At 52 weeks, 65% in the aflibercept 2q16 group and 80% in the aflibercept 2q8/PRN group showed a two-step or greater improvement in DRSS, compared to 15% in the control group (P<0.001).
Through week 100, significantly fewer eyes treated with aflibercept developed vision-threatening complications or center-involved diabetic macular edema (16% of the 2q16 group, 19% of the 2q8/PRN group and 50% of the control group).
Overall, no differences in visual acuity were noted at two years, the researchers report in JAMA Ophthalmology. But in a post hoc analysis of the participants with vision-threatening complications or center-involved diabetic macular edema (CI-DME), more in the control group experienced a letter loss of five or more letters.
“Fixed intravitreal aflibercept injection dosing in a patient population who adhered to the treatment regimen was demonstrated to be safe and effective in preventing vision-threatening complications and CI-DME in eyes with severe NPDR,” the investigators conclude.
Dr. Shriji Patel of Vanderbilt University Medical Center in Memphis, Tennessee, told Reuters Health by email, “Overall, significantly fewer eyes treated with intravitreal aflibercept versus sham injections developed vision-threatening complications and/or CI-DME.”
However, Dr. Patel, an assistant professor of ophthalmology and visual sciences who was not involved in the research, pointed out that “discontinuation or reduction in the frequency of therapy may lead to PDR-related complications. This means there is no clear endpoint for anti-VEGF treatment in these individuals.”
The study was sponsored by Regeneron Pharmaceuticals, which market aflibercept as Eyelea. Dr. Wykoff and other authors have ties to the company.
SOURCE: https://bit.ly/3ivSCfo JAMA Ophthalmology, online August 5, 2021.
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