| Title: |
COMBINED INTRAVITREAL AFLIBERCEPT AND ANTI-INFLAMMATORY ORAL SUPPLEMENTATION IN THE TREATMENT OF DIABETIC MACULAR EDEMA: Two-Year Randomized Controlled Trial Results |
| Authors: |
Marolo P.; Volti G. L.; Nicolosi A.; Avitabile T.; Longo A.; Fallico M.; Russo A.; Borrelli E.; Parisi G.; Toro M. D.; De Sanctis U.; Motta L.; Reibaldi M. |
| Contributors: |
Marolo, P.; Volti, G. L.; Nicolosi, A.; Avitabile, T.; Longo, A.; Fallico, M.; Russo, A.; Borrelli, E.; Parisi, G.; Toro, M. D.; De Sanctis, U.; Motta, L.; Reibaldi, M. |
| Publisher Information: |
LIPPINCOTT WILLIAMS & WILKINS |
| Publication Year: |
2025 |
| Collection: |
Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Subject Terms: |
Lenidase; aflibercept; anti-inflammatory therapy; diabetic macular edema; injection frequency |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39977849; info:eu-repo/semantics/altIdentifier/wos/WOS:001508473400019; volume:45; issue:6; firstpage:1134; lastpage:1142; numberofpages:9; journal:RETINA; https://hdl.handle.net/11577/3588622 |
| DOI: |
10.1097/IAE.0000000000004427 |
| Availability: |
https://hdl.handle.net/11577/3588622; https://doi.org/10.1097/IAE.0000000000004427 |
| Accession Number: |
edsbas.7EAF343E |
| Database: |
BASE |