Luis Acaba-Berrocal MD
Wills Eye Hospital, Philadelphia, PA
The Late-Breaking Abstract session at Retina Subspecialty Day highlighted several important clinical trials in diabetic macular edema and diabetic retinopathy. Among them was the NEW DAY study, presented by Dr. Victor Gonzalez.
Dr. Gonzalez began by emphasizing that DME remains a major cause of visual impairment worldwide. Although anti-VEGF agents have markedly improved outcomes, maintaining visual gains often requires a high treatment burden with frequent injections.
The goal of the NEW DAY study was to directly compare anti-VEGF (aflibercept 2 mg) versus a corticosteroid implant (fluocinolone acetonide 0.19 mg) for the management of center-involving DME. Eligible participants were treatment-naïve patients with central subfield thickness greater than 350 µm. Patients with proliferative diabetic retinopathy, prior panretinal photocoagulation, glaucoma, or prior intraocular steroid exposure were excluded.
This was a multicenter randomized trial conducted across 42 U.S. sites between 2020 and 2025, enrolling 306 eyes with an 18-month follow-up period. In the loading phase, patients in the aflibercept arm received five monthly injections, while the fluocinolone group received a single implant followed by either sham or supplemental aflibercept injections monthly for five months. During the maintenance phase, both groups could receive supplemental aflibercept based on predefined retreatment criteria, including persistent or worsening DME or vision loss.
The primary endpoint was the mean number of supplemental aflibercept injections required through month 18. Secondary endpoints included changes in best-corrected visual acuity, CST, adverse events, and the proportion of patients not requiring supplemental therapy.
Overall, baseline demographics were well balanced between groups, with a mean patient age of 62 years. Dr. Gonzalez reported that there was no significant difference between groups in the number of supplemental aflibercept injections required or in the proportion of patients who needed no additional treatment (approximately 30% in each group). However, the mean total number of injections was lower in the fluocinolone group (3.4 vs. 7.5 injections in the aflibercept arm), representing a substantial reduction in overall treatment burden.
Regarding secondary outcomes, visual acuity improvement favored the aflibercept group, likely due to higher rates of cataract progression in the steroid implant arm. Among pseudophakic patients, however, there was no significant difference in BCVA between groups. Both treatment arms had comparable rates of adverse events, with the steroid group showing expected increases in cataract formation and ocular hypertension.
Dr. Gonzalez concluded by highlighting the following key takeaways:
- The NEW DAY study provides high-quality evidence comparing long-acting steroid implants with anti-VEGF therapy in treatment-naïve DME.
- While visual outcomes and need for supplemental injections were similar, the fluocinolone implant reduced the total number of injections required over 18 months.
- These results further support the role of corticosteroid implants as a valuable option in the management of DME, particularly for patients seeking to reduce treatment burden.
