Dedania VS. Protocol V and its application to clinical practice. Presented at: OSN New York and OSN New York Retina; Oct. 17-18, 2020 (virtual meeting).
Protocol V provides framework for center-involved DME treatment
The results of Protocol V provide the framework for a treatment strategy of patients in clinical practice with center-involved diabetic macular edema and good vision, according to a speaker.
“Ultimately, the framework here is an observe-and-extend, as opposed to a treat-and-extend,” Vaidehi S. Dedania, MD, said at the virtual OSN New York Retina meeting.
The DRCR Retina Network Protocol V evaluated treatment for center-involved diabetic macular edema (DME) in eyes with visual acuity of 20/25 or better. The randomized clinical trial evaluated Eylea (aflibercept, Regeneron) vs. laser with rescue aflibercept vs. observation with rescue aflibercept. The primary outcome of the trial was the proportion of eyes that lost five or more letters of visual acuity at 2 years, Dedania said.
At 2 years, the rates of visual acuity loss of five or more letters did not differ significantly between groups, and the majority of eyes in the observation and laser photocoagulation groups did not receive aflibercept, she said.
In the aflibercept group, treatment was administered at baseline and patients were evaluated every 4 weeks for 24 weeks. If visual acuity decreased or central subfield thickness increased over two visits, then aflibercept was administered. If patients were stable over two visits, then aflibercept was deferred. If aflibercept was deferred over three visits after the initial 24 weeks, follow-up was extended to 8 weeks and then 16 weeks.
The laser group had treatment administered at baseline, then every 13 weeks as needed. The initial follow-up was at 8 weeks, then extended to every16 weeks. If visual acuity decreased by 10 letters over one visit, or five to nine letters over two visits, rescue aflibercept was administered. This protocol for rescue aflibercept was also used in the observation group, she said.
“When we apply the results of Protocol V to clinical practice, we have to apply the criteria of the patients in the study to our own patients and identify outliers,” she said.
Patients in Protocol V had a mean baseline visual acuity of 20/20, a mean central-subfield thickness of 311 µm, a mean hemoglobin A1c of 7.6% and overall had good glycemic control. Additionally, 55% to 62% had mild to moderate nonproliferative diabetic retinopathy and 4% to 8% had proliferative diabetic retinopathy, she said.
“When applying the results of Protocol V to our patient population remember to consider the level of diabetic retinopathy, glycemic control and other factors. Finally, close follow-up is critical for maintaining visual acuity,” she said.