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

Glaucoma Clinical Trial

— MCToCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440751
• Other study ID #: AAE-CT-USA-2010-02
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2011
• Last updated: October 30, 2017
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Aeon Astron Europe B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Glaucoma Associates of New York	New York	New York
United States	New York Eye and Ear Infirmary	New York	New York
United States	Institue of Ophthalmology and Visual Science	Newark	New Jersey
United States	Dean McGee Eye Institue	Oklahoma City	Oklahoma
United States	Wills Eye Institue	Philadelphia	Pennsylvania
United States	VoldVision-Holf Eye Clinic	Rogers	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Aeon Astron Europe B.V.	Glaucoma Associates of New York, The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.