Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany

Open-angle Glaucoma Clinical Trial

Official title:

A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01174420
• Other study ID #: AAE-CT-DEU-2009-01
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2010
• Last updated: May 5, 2011
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: May 2011
• Source: Aeon Astron Europe B.V.
• Contact: Thomas Dietlein, MD
• Phone: +49-221-478-5862
• Email: thomas.dietlein[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

Description:

ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.

The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or over

• Uncontrolled open-angle glaucoma

• Subject is willing to sign informed consent

• Subject is able and willing to complete post-operative follow-up requirements

Exclusion Criteria:

• Inflammatory eye diseases

• Angle-closure glaucoma

• Secondary glaucoma with anatomical malformations of the eye

• Subjects having single functional eye

• Previous conjunctival surgery

• Known allergic reactions to ingredients of ologen Collagen Matrix

• Excessive myopia (axial length (AL)> 27 mm or more than -10 diopters)

• Previous vitrectomy eye surgery

• Subjects do not consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Device:
• Use of ologen Collagen Matrix in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing

Drug:
• Use of Mitomycin-C in trabeculectomy
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.

Locations

Country	Name	City	State
Germany	The University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Aeon Astron Europe B.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) reduction		6 months	No
Secondary	Incidence of complications		6 months	Yes