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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Use of ologen Collagen Matrix in trabeculectomy (ologen); Drug: Use of Mitomycin-C (MMC) in trabeculectomy

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72756
      • VoldVision-Holf Eye Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Institue of Ophthalmology and Visual Science
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary
    • New York, New York, United States, 10003
      • Glaucoma Associates of New York
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institue
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institue
  • Texas
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure(IOP) reduction	"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.	At postoperative up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications and appearances	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.	At postoperative up to 24 months.

Collaborators and Investigators

• Sponsor: Aeon Astron Europe B.V.
• Collaborators: 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

Publications and helpful links

General Publications

• Tanna AP, Rademaker AW, de Moraes CG, Godfrey DG, Sarkisian SR Jr, Vold SD, Ritch R. Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial. BMC Ophthalmol. 2016 Dec 29;16(1):217. doi: 10.1186/s12886-016-0393-z.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 23, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: glaucoma; trabeculectomy; mitomycin-C; filtering surgery; ologen collagen matrix
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: AAE-CT-USA-2010-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No