Title
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Phase
Phase 4Lead Sponsor
Aeon Astron Europe B.V.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
GlaucomaStudy Participants
99The 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.
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.
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.
When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva
When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva
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
