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Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aeon Astron Europe B.V.
ClinicalTrials.gov Identifier:
NCT01440751
First received: September 14, 2011
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.


Condition Intervention Phase
Glaucoma
Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)
Drug: Use of Mitomycin-C (MMC) in trabeculectomy
Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Intraocular pressure(IOP) reduction [ Time Frame: At postoperative up to 24 months. ] [ Designated as safety issue: No ]

    "Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP.

    Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size.

    "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters.

    In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months.



Secondary Outcome Measures:
  • Postoperative complications and appearances [ Time Frame: At postoperative up to 24 months. ] [ Designated as safety issue: Yes ]

    Inspections of hyphema, severe anterior chamber reaction, hypotony, supercholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak.

    Visual acuity, bleb appearance, and anterior chamber inflammation.



Estimated Enrollment: 128
Study Start Date: February 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ologen Collagen Matrix Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)
Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
Active Comparator: Mitomycin-C (MMC) Drug: Use of Mitomycin-C (MMC) in trabeculectomy
After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.

Detailed Description:

"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study.

Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.

The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 30 years (inclusive)
  • Uncontrolled treated glaucoma requiring trabeculectomy
  • Subject must be able and willing to cooperate with investigation plan
  • Subject must be able and willing to complete postoperative follow-up requirements
  • subject must be willing to sign informed consent form

Exclusion Criteria:

  • Known allergic reaction to MMC or porcine collagen
  • Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
  • Prior cataract unless clear corneal incision
  • Previous conjunctival or strabismus surgery
  • Participation in an investigational study during 30 days prior to trabeculectomy
  • Ocular infection within 14 days prior to trabeculectomy
  • Pregnant or breast-feeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440751

Locations
United States, Arkansas
VoldVision-Holf Eye Clinic
Rogers, Arkansas, United States, 72756
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, New Jersey
Institue of Ophthalmology and Visual Science
Newark, New Jersey, United States, 07103
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Oklahoma
Dean McGee Eye Institue
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Wills Eye Institue
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Aeon Astron Europe B.V.
Investigators
Principal Investigator: Robert Ritch, MD Glaucoma Associates of New York
Study Director: Steven Sarkisian, MD Dean McGee Eye Institute
Study Director: Robert Fechtner, MD Institute of Ophthalmology and Visual Science
Study Director: Michael Pro, MD Wills Eye Institue
Study Director: Steven Vold, MD Boozman-Hof Eye Clinic
Study Director: Angelo Tanna, MD Northwestern Memorial Hospital
Study Director: David Godfrey, MD Glaucoma Associates of Texas
Study Director: Paul Sidoti, MD New York Eye and Ear Infirmiry
  More Information

No publications provided

Responsible Party: Aeon Astron Europe B.V.
ClinicalTrials.gov Identifier: NCT01440751     History of Changes
Other Study ID Numbers: AAE-CT-USA-2010-02
Study First Received: September 14, 2011
Last Updated: December 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Aeon Astron Europe B.V.:
ologen collagen matrix
mitomycin-C
trabeculectomy
glaucoma
filtering surgery

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

ClinicalTrials.gov processed this record on November 24, 2014