Purpose: To compare intravitreal aflibercept alone versus aflibercept combined with oral anti-inflammatory supplementation in patients with diabetic macular edema (DME). Methods: A prospective, randomized study included 134 treatment-naive eyes with central-involving DME. 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 (T&E) regimen. The primary outcome was the number of injections over 24 months. Secondary outcomes included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), 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 BCVA: 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). CMT also significantly decreased in both groups (P < 0.0001). No significant differences were found between the groups for vision improvement (P=0.918) or CMT reduction (P=0.777). No ocular complications were reported. Conclusions: Oral supplementation with Lenidase® showed similar efficacy to aflibercept monotherapy in DME, with fewer injections, potentially reducing treatment burden.
Combined Intravitreal Aflibercept and Anti-inflammatory Oral Supplementation in the Treatment of Diabetic Macular Edema: Two-Year Randomized Controlled Trial Results
Marolo, Paola;Borrelli, Enrico;de Sanctis, Ugo;Reibaldi, Michele
2025-01-01
Abstract
Purpose: To compare intravitreal aflibercept alone versus aflibercept combined with oral anti-inflammatory supplementation in patients with diabetic macular edema (DME). Methods: A prospective, randomized study included 134 treatment-naive eyes with central-involving DME. 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 (T&E) regimen. The primary outcome was the number of injections over 24 months. Secondary outcomes included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), 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 BCVA: 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). CMT also significantly decreased in both groups (P < 0.0001). No significant differences were found between the groups for vision improvement (P=0.918) or CMT reduction (P=0.777). No ocular complications were reported. Conclusions: Oral supplementation with Lenidase® showed similar efficacy to aflibercept monotherapy in DME, with fewer injections, potentially reducing treatment burden.
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