COMBINED INTRAVITREAL AFLIBERCEPT AND ANTI-INFLAMMATORY ORAL SUPPLEMENTATION IN THE TREATMENT OF DIABETIC MACULAR EDEMA: Two-Year Randomized Controlled Trial Results

Purpose:To compare intravitreal aflibercept alone versus aflibercept combined with oral anti-inflammatory supplementation in patients with diabetic macular edema. Methods:A prospective, randomized study included 134 treatment-naive eyes with central-involving diabetic macular edema. Participants were assigned to receive either intravitreal aflibercept (Group A) or aflibercept with oral Lenidase supplementation (Group B, containing baicalin, bromelain, and escin). Both groups followed a treat-and-extend regimen. The primary outcome was the number of injections over 24 months. Secondary outcomes included changes in best-corrected visual acuity, central macular thickness, and safety assessments. Results:At 24 months, Group A required a mean of 14.34 +/- 0.51 injections, while Group B required 12.96 +/- 0.44 (P < 0.0001). Both groups showed significant improvement in best-corrected visual acuity: from 0.62 +/- 0.12 logMAR (20/83 Snellen) to 0.43 +/- 0.13 logMAR (20/54 Snellen) in Group A and from 0.64 +/- 0.13 logMAR (20/87 Snellen) to 0.42 +/- 0.15 logMAR (20/53 Snellen) in Group B (P < 0.0001 for both). Central macular thickness also significantly decreased in both groups (P < 0.0001). No significant differences were found between the groups for vision improvement (P = 0.918) or central macular thickness reduction (P = 0.777). No ocular complications were reported. Conclusion:Oral supplementation with Lenidase showed similar efficacy to aflibercept monotherapy in diabetic macular edema, with fewer injections, potentially reducing treatment burden.