A secondary analysis of the Diabetic Retinopathy Clinical Research (DRCR) Retina Network Protocol V has determined that most eyes with center-involved diabetic macular edema (DME) and good visual acuity (VA) initially managed with observation did not require subsequent anti-VEGF for VA loss. On average, eyes in the initial observation group that required anti-VEGF treatment because of VA worsening still achieved good visual outcomes at two years.

The study assessed the clinical trial’s 236 patients with center-involved DME and a VA letter score of at least 79. The protocol dictated that clinicians initiate follow-up with anti-VEGF only for VA loss of at least 10 letters from baseline at one visit or five to nine letters at two consecutive visits. Follow-up occurred at eight weeks and then every 16 weeks, unless VA or OCT central subfield thickness worsened. Only 80 (34%) were treated with anti-VEGF during the two years of follow-up. Most eyes managed with initial observation plus anti-VEGF only if VA worsened maintained good vision at two years and did not require treatment for VA loss.

Among eyes in the observation group that lost one line of VA at any visit, 46% tested better at the next visit and did not require anti-VEGF at any subsequent time during the trial. “Thus, when vision loss is less than two lines (10 letters), the approach of confirming sustained vision loss before initiating anti-VEGF therapy in eyes with good vision appears to be reasonable,” the researchers wrote. “Eyes with good VA despite center-involved DME often experience spontaneous resolution of retinal thickening, further supporting initial observation as a management approach.”