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

Primary Purpose

Open-angle Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Use of ologen Collagen Matrix in trabeculectomy
Use of Mitomycin-C in trabeculectomy
Sponsored by
Aeon Astron Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Open-angle Glaucoma focused on measuring ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University Hospital of CologneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ologen Collagen Matrix

Mitomycin-C (MMC)

Arm Description

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP) reduction

Secondary Outcome Measures

Incidence of complications

Full Information

First Posted
August 2, 2010
Last Updated
May 5, 2011
Sponsor
Aeon Astron Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01174420
Brief Title
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
Official Title
A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aeon Astron Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ologen Collagen Matrix
Arm Type
Experimental
Arm Title
Mitomycin-C (MMC)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Use of ologen Collagen Matrix in trabeculectomy
Intervention Description
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
Intervention Type
Drug
Intervention Name(s)
Use of Mitomycin-C in trabeculectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP) reduction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of complications
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Dietlein, MD
Phone
+49-221-478-5862
Ext
4300
Email
thomas.dietlein@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dietlein, MD
Organizational Affiliation
Department of Ophthalmology, University of Cologne, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Dietlein, MD
Phone
+49-221-478-5862
Ext
4300
Email
thomas.dietlein@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Thomas Dietlein, MD

12. IPD Sharing Statement

Learn more about this trial

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

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