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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:30 - Any
Updated:11/3/2017
Start Date:September 2011
End Date:December 2015

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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.

"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.

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
We found this trial at
8
sites
Rogers, Arkansas 72756
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Rogers, AR
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Dallas, Texas 75231
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Dallas, TX
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New York, New York 10003
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New York, NY
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New York, New York
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New York, NY
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Newark, NJ
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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