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J Glaucoma. 2019 Feb 21. doi: 10.1097/IJG.0000000000001215. [Epub ahead of print]

Effect of Two Novel Sustained- Release Drug Release Systems on Bleb Fibrosis: An In Vivo Trabeculectomy Study in a Rabbit Model.

Author information

1
Department of Ophthalmology, Tulane University School of Medicine, New Orleans, Louisiana, USA.
2
Departments of Anesthesia and Surgery, Harvard Medical School, Boston, Massachusetts, USA.
3
Department of Biochemistry and Molecular Biology, Tulane University School of Medicine, New Orleans, Louisiana, USA.
4
Department of Ophthalmology, University of South Florida, Tampa, Florida, USA.

Abstract

PRECIS:

Rabbit model studies suggested better morphology blebs with equal IOP efficacy as a standard MMC Trabeculectomy using a novel slow release drug delivery anti-fibrotic system delivering small quantities of MMC and 5 FU.

PURPOSE:

To evaluate two different concentrations of biodegradable poly(lactic-co-glycolic acid) (PLGA) system with 5-fluorouracil (5-FU) and mitomycin C (MMC) (ElutiGLASS) for their ability to reduce fibrosis and compare the results to standard trabeculectomy with MMC in a rabbit model.

METHODS:

New Zealand albino rabbits (19) were divided into 3 groups (A, B, C) and standard trabeculectomy operation was performed in the right eye of each rabbit.Group (A) had Trabeculectomy with MMC (0.4▒mg/cc) applied using a Weck cell sponge; (B) Trabeculectomy with slow release ElutiGLASS (0.23▒mg 5-FU/0.33▒μg MMC released over 23- 30▒d ); (C) Trabeculectomy with rapid release ElutiGLASS (0.45▒mg of 5-FU /0.65▒μg MMC, released over 5-7▒d). The rabbits were followed for 3 months prior to euthanasia.

RESULTS:

Bleb morphology, vascularity, and fibrosis were less pronounced in groups B and C when compared to Group A at 3 months. Group B appears to have a lower and more diffuse bleb appearance compared to the other two groups with honeycomb appearance on both clinical examination and UBM with higher percentage of maintained bleb space (83%), less fibrosis than Group A while maintaining the same low inflammation score as the other two groups on histology. At 3 months, the PLGA polymer had completely disappeared in all rabbits. There were no statistical differences in the degree of IOP reduction or histologic inflammation, among the 3 groups.

CONCLUSIONS:

We successfully created a sustained-release anti-fibrotic drug delivery system that delivered known dosage of the drugs at doses that are significantly lower than the current standard, and resulted in less fibrosis while maintaining a healthy bleb and equal reduction of intraocular pressure.

TRANSLATIONAL RELEVANCE:

These results are supportive of the antifibrotic effect of the slow-release drug delivery system used in conjunction with trabeculectomy, thus paving the way for human pilot studies to improve and simplify existing surgical techniques for filtering surgeries in glaucoma.

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