Early pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling may provide durable visual and anatomic benefits for carefully selected patients with treatment-naïve diabetic macular edema (DME), according to findings presented at the Retina World Congress in Fort Lauderdale, Florida. 

Matias Iglicki, MD, of the University of Buenos Aires, discussed results from the 2018 VITAL Study, a multicenter investigation he co-led. He said the study was designed to address a persistent challenge in DME management: the gap between outcomes achieved in clinical trials and those seen in real-world practice.  

“Anti-VEGF therapy remains the standard first-line treatment for center-involved DME, but we wanted to explore whether surgery could play a role in selected patients unwilling or unable to adhere to frequent injection schedules,” he said. 

The VITAL study included 120 eyes from 120 patients with treatment-naïve DME who underwent 25-gauge PPV with ILM peeling. Patients were followed for 24 months without additional DME treatment. None of the patients required supplemental anti-VEGF therapy, steroid injections, or macular laser during follow-up. 

At 24 months, patients demonstrated significant improvements in both visual acuity and retinal thickness. Mean best-corrected visual acuity improved from 0.66 logMAR at baseline to 0.53 logMAR, while central subfield thickness decreased from approximately 593 microns to 230 microns. More than 43% of patients gained at least five ETDRS letters, and 31.7% gained 10 or more letters. 

One of the study’s most notable findings involved the timing of intervention. Earlier surgery was strongly associated with better visual outcomes. “For every day we postponed the vitrectomy, the chances to gain five or more letters on the ETDRS chart decreased 1.8%,” said Dr. Iglicki. 

The study also identified several OCT biomarkers associated with favorable surgical outcomes, including subretinal fluid, preserved IS/OS integrity, and relatively recent-onset DME. “These made for the good candidates,” said Dr. Iglicki. He also noted that eyes with chronic edema and photoreceptor damage experienced less visual improvement despite anatomic gains. 

The safety profile was generally consistent with expectations for vitrectomy. Cataract progression occurred in phakic patients during the 24-month follow-up period. Twenty patients (16.7%) required IOP-lowering medication, though all were successfully managed with topical timolol 0.5% twice daily, and no patient required glaucoma surgery.  

Despite the encouraging findings, Dr. Iglicki stressed that PPV with ILM peeling should not replace anti-VEGF therapy for most patients. “Anti-VEGF is the first-line option,” he said. “But in suitable patients that are not willing to have anti-VEGF injections, I think vitrectomy plays a major role.” RP