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Randomized Controlled Trial
. 2025 Jun 1;45(6):1134-1142.
doi: 10.1097/IAE.0000000000004427.

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

Paola Marolo  1 , Giovanni Li Volti  2 , Anna Nicolosi  3 , Teresio Avitabile  4 , Antonio Longo  4 , Matteo Fallico  4 , Andrea Russo  4 , Enrico Borrelli  1 , Guglielmo Parisi  1 , Mario Damiano Toro  5   6 , Ugo de Sanctis  1 , Lorenzo Motta  7 , Michele Reibaldi  1
Affiliations
Randomized Controlled Trial

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

Paola Marolo et al. Retina. .

Abstract

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.

Keywords: Lenidase; aflibercept; anti-inflammatory therapy; diabetic macular edema; injection frequency.

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References

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