Clinical trial NCT01440751: Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Official title: Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: ologen collagen matrix
mitomycin-C
trabeculectomy
glaucoma
filtering surgery
Lead sponsor: Aeon Astron Europe B.V.
Sponsor class: INDUSTRY
Collaborators: name: The New York Eye & Ear Infirmary
name: Robert Ritch, MD, LLC.
First posted: 2011-09-27
Enrollment: 99
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Intraocular pressure(IOP) reduction
timeFrame: At postoperative up to 24 months.
Secondary outcomes:
measure: Postoperative complications and appearances
timeFrame: At postoperative up to 24 months.
Other outcomes:
Locations:
city: Rogers
country: United States
facility: VoldVision-Holf Eye Clinic
state: Arkansas
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Newark
country: United States
facility: Institue of Ophthalmology and Visual Science
state: New Jersey
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institue
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills Eye Institue
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
Study officials:
affiliation: Robert Ritch, MD, LLC.
name: Robert Ritch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean McGee Eye Institute
name: Steven Sarkisian, MD
role: STUDY_DIRECTOR
affiliation: Institute of Ophthalmology and Visual Science
name: Robert Fechtner, MD
role: STUDY_DIRECTOR
affiliation: Wills Eye Institue
name: Michael Pro, MD
role: STUDY_DIRECTOR
affiliation: Boozman-Hof Eye Clinic
name: Steven Vold, MD
role: STUDY_DIRECTOR
affiliation: Northwestern Memorial Hospital
name: Angelo Tanna, MD
role: STUDY_DIRECTOR
affiliation: Glaucoma Associates of Texas
name: David Godfrey, MD
role: STUDY_DIRECTOR
affiliation: New York Eye and Ear Infirmiry
name: Paul Sidoti, MD
role: STUDY_DIRECTOR
References:
citation: 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.