Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
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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 |
- 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.
- 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 2012 (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 |
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| Contact: Robert Ritch, MD | 212-673-5140 | ritchmd@earthlink.net |
| United States, Arkansas | |
| VoldVision-Holf Eye Clinic | Recruiting |
| Rogers, Arkansas, United States, 72756 | |
| Contact: Steven Vold, MD 479-246-1700 svold@cox.net | |
| Principal Investigator: Steven Vold, MD | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Theodore Krupin, MD 312-475-1000 krupin@northwestern.edu | |
| Principal Investigator: Theodore Krupin, MD | |
| United States, New Jersey | |
| Institue of Ophthalmology and Visual Science | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Robert Fechtner, MD 973-972-0205 fechtnrd@umdnj.edu | |
| Principal Investigator: Robert Fechtner, MD | |
| United States, New York | |
| Glaucoma Associates of New York | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Robert Ritch, MD 212-673-5140 ritchmd@earthlink.net | |
| Principal Investigator: Robert Ritch, MD | |
| New York Eye and Ear Infirmary | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Paul Sidoti, MD 212-477-7540 psidoti@nyee.edu | |
| Principal Investigator: Paul Sidoti, MD | |
| United States, Oklahoma | |
| Dean McGee Eye Institue | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Steven Sarkisian, MD 405-271-1093 Steven-sarkisian@dmei.org | |
| Principal Investigator: Steven Sarkisian, MD | |
| United States, Pennsylvania | |
| Wills Eye Institue | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Michael Pro, MD 917-254-2455 mpro2020@yahoo.com | |
| Principal Investigator: Michael Pro, MD | |
| United States, Texas | |
| Glaucoma Associates of Texas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: David Godfrey, MD 214-360-0000 dgodfrey@glaucomaassociates.com | |
| Principal Investigator: David Godfrey, MD | |
| 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: | January 19, 2012 |
| 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 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 May 23, 2013