MCToCM: Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

Sponsor
Aeon Astron Europe B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT01440751
Collaborator
The New York Eye & Ear Infirmary (Other), Robert Ritch, MD, LLC. (Other)
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)
  • Drug: Use of Mitomycin-C (MMC) in trabeculectomy
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: ologen Collagen Matrix

When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva

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)

When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva

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.

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure(IOP) reduction [At postoperative up to 24 months.]

    "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

  1. Postoperative complications and appearances [At postoperative up to 24 months.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VoldVision-Holf Eye Clinic Rogers Arkansas United States 72756
2 Northwestern Memorial Hospital Chicago Illinois United States 60611
3 Institue of Ophthalmology and Visual Science Newark New Jersey United States 07103
4 Glaucoma Associates of New York New York New York United States 10003
5 New York Eye and Ear Infirmary New York New York United States 10003
6 Dean McGee Eye Institue Oklahoma City Oklahoma United States 73104
7 Wills Eye Institue Philadelphia Pennsylvania United States 19107
8 Glaucoma Associates of Texas Dallas Texas United States 75231

Sponsors and Collaborators

  • Aeon Astron Europe B.V.
  • The New York Eye & Ear Infirmary
  • Robert Ritch, MD, LLC.

Investigators

  • Principal Investigator: Robert Ritch, MD, Robert Ritch, MD, LLC.
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aeon Astron Europe B.V.
ClinicalTrials.gov Identifier:
NCT01440751
Other Study ID Numbers:
  • AAE-CT-USA-2010-02
First Posted:
Sep 27, 2011
Last Update Posted:
Nov 1, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Aeon Astron Europe B.V.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2017