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Improvement to trabeculectomy

a trabeculectomy and surgery technology, applied in the field of trabeculectomy surgery, can solve the problems of surgical failure, antimetabolites carry a risk of vision-threatening complications, loss of visual field, etc., and achieve the effect of preventing, reducing or retarding the occurrence of filtration failur

Inactive Publication Date: 2012-07-26
THROMBOGENICS NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]The invention relates to (the use of) a plasmin or an active truncated variant thereof (for the manufacture of a medicament) for treating filtration failu

Problems solved by technology

This disease is characterized by progressive retinal ganglion cell apoptosis, resulting in visual field loss.
In 30% of the cases, however, the constructed channel closes due to excessive scar tissue formation, resulting in surgical failure (Addicks et al., 1983, Arch Ophthalmol 101, 795-798).
However, these antimetabolites carry a risk of vision-threatening complications such as scleral thinning and infections (Lama & Fechtner, 2003; Hitchings & Grierson, 1983; Skuta & Parrish, 1987; Jampel et al., 1988; Gillies & Su, 1991; Katz et al., 1995; Greenfield et al., 1998, Arch Ophthalmol 116, 443-447).
Furthermore, blocking TGF-β seemed promising in animal models (Cordeiro et al., 2003, Gene Ther 10, 59-71), but was not efficient in a clinical study (CAT-152 0102 Trabeculectomy Study Group, Kwah, Grehn, 2007, Ophthalmol 114, 1822-1830).

Method used

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  • Improvement to trabeculectomy

Examples

Experimental program
Comparison scheme
Effect test

example 1

Rabbit Model for Glaucoma Filtration Surgery

[0049]Female New-Zealand rabbits, aged 12 to 14 weeks and weighing 2 to 3 kg, underwent a filtration surgery (trabeculectomy) in both eyes in the same way as in human eyes, except that in rabbits a much more aggressive postoperative fibrosis occurs, resulting in a filtration failure after 10 to 14 days (Miller et al., 1985, Trans Ophthalmol Soc UK 104, 893-897).

[0050]General anesthesia was induced with an intramuscular injection of Ketalar (50 mg / ml) and Rompun (2%). Before the operation the IOP was measured in both eyes by using the Tono-Pen® tonometer (Medtronic Solan) under topical anesthesia (Unicain, 4 mg / ml).

[0051]Briefly, for the trabeculectomy a Vicryl 9 / 0 corneal traction suture was placed superiorly and the eye was pulled down. A limbus-based conjunctival flap was raised after which a blunt dissection of subconjunctival space was performed. After a scleral flap of 5 mm to 5 mm was formed, a piece of the trabecular meshwork was re...

example 2

Immunohistochemical Investigation

[0053]On day 30 after surgery, rabbits were killed using a lethal intravenous injection of Rompun under general anesthesia. Both eyes were enucleated, fixed overnight in 4% PFA and embedded in paraffin. Seven-μm thin slides were (immuno-)stained for CD45 to evaluate inflammation and for Sirius red and Trichrome to evaluate fibrosis.

A. Collagen Deposition

[0054]Sirius Red and Trichrome staining were used to demonstrate collagen deposition. After Sirius red staining collagen is colored red; after Trichrome staining collagen is colored blue (aniline blue, 5 minutes), nuclei black (Weigert hematoxyline, 10 minutes), and cytoplasm red (Biebrich scarlet fuchsin, 2 minutes).

B. Inflammation

[0055]A CD45 staining was performed to study inflammatory cells. After a 20 minutes incubation with methanol and 45 minutes with PIR (1 / 5; Dakocytomation) the samples were incubated overnight with mouse anti-rabbit CD45 antibody (1 / 3, 10-50 μg / ml; MCA808; AbDSerotec). The n...

example 3

Effect of Microplasmin on Blebs after Trabeculectomy on Rabbit Eyes

[0056]Group 1: Filtration surgery followed by injection in the anterior chamber of microplasmin on day 0: immediately after the trabeculectomy operation 10 rabbits got an anterior chamber injection of microplasmin (200 μl of a solution of 2,5 mg microplasmin / mL in 5 mM citric acid, 6 mg / mL mannitol, pH 3.1). Ten other rabbits underwent trabeculectomy followed by control injections of the same volume of 0.9% NaCl.

[0057]Group 2: Filtration surgery followed by administration of topical eye drops containing microplasmin: immediately after the trabeculectomy operation on 3 rabbits, microplasmin was administered in the form of topical eye drops (4 mg microplasmin / mL in 5 mM citric acid, 6 mg / mL mannitol, pH 3.1; 1 drop of ca. 50-55 μL was administered 4 times per day during a period of 14 days). Three other rabbits underwent trabeculectomy followed by administration of control eye drops of 0.9% NaCl.

[0058]Group 3: Filtrati...

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Abstract

The current invention relates to the improvement of trabeculectomy surgery. The improvement more specifically resides in an extended lifetime of the sclera-corneal drainage channel created by trabeculectomy surgery. The improvement is obtained by post-surgical administration of a plasmin or active derivative thereof in the form of topical eye drops alone, by anterior chamber injection alone, or by any combination of these.

Description

FIELD OF THE INVENTION[0001]The current invention relates to the improvement of trabeculectomy surgery. The improvement more specifically resides in an extended lifetime of the sclera-corneal drainage channel created by trabeculectomy surgery. The improvement is obtained by post-surgical administration of a plasmin or active derivative thereof in the form of topical eye drops alone, by anterior chamber injection alone, or by any combination of these.BACKGROUND OF THE INVENTION[0002]Glaucoma is a multifactorial, neurodegenerative disease and the second most important cause of irreversible blindness (Quigley, 1996, Br J Ophthalmol 80, 389-393). This disease is characterized by progressive retinal ganglion cell apoptosis, resulting in visual field loss. Current treatment of this disease is directed towards the reduction of intraocular pressure (IOP), which is the main risk factor for glaucoma (Collaborative Normal-Tension Glaucoma Study Group, 1998, Am J Opthalmol 126, 487-497).[0003]O...

Claims

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Application Information

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IPC IPC(8): A61K38/48A61P31/12A61P27/08A61P27/02A61P23/02C12N9/68A61P29/00
CPCA61K9/0048A61K9/0051A61K45/06A61K47/12A61K38/484A61P23/02A61P27/02A61P27/08A61P29/00A61P31/12
Inventor STASSEN, JEAN-MARIESTALMANS, INGEBORG
Owner THROMBOGENICS NV