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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Aeon Astron Europe B.V..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aeon Astron Europe B.V.
ClinicalTrials.gov Identifier:
NCT01174420
First received: August 2, 2010
Last updated: May 5, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Open-angle Glaucoma
 Device: Use of ologen Collagen Matrix in trabeculectomy
Drug: Use of Mitomycin-C in trabeculectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
Drug Information available for: Mitomycin
U.S. FDA Resources

Further study details as provided by Aeon Astron Europe B.V.:

Primary Outcome Measures:
  • Intraocular pressure (IOP) reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ologen Collagen Matrix 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
Active Comparator: Mitomycin-C (MMC) 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174420

Contacts
Contact: Thomas Dietlein, MD +49-221-478-5862 ext 4300 thomas.dietlein@uk-koeln.de

Locations
Germany
The University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Thomas Dietlein, MD     +49-221-478-5862 ext 4300     thomas.dietlein@uk-koeln.de    
Principal Investigator: Thomas Dietlein, MD            
Sponsors and Collaborators
Aeon Astron Europe B.V.
Investigators
Principal Investigator: Thomas Dietlein, MD Department of Ophthalmology, University of Cologne, Germany
  More Information

No publications provided

Responsible Party: Thomas Dietlein, Department of Ophthalmology, University of Cologne, Germany
ClinicalTrials.gov Identifier: NCT01174420     History of Changes
Other Study ID Numbers: AAE-CT-DEU-2009-01
Study First Received: August 2, 2010
Last Updated: May 5, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Aeon Astron Europe B.V.:
ologen
Mitomycin-C
Collagen Matrix
 trabeculectomy
glaucoma
filtering surgery

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on June 13, 2013