GlaucomaPhase 4MCToCMNCT01440751
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
A Phase 4 study testing Use of ologen Collagen Matrix in trabeculectomy (ologen) and Use of Mitomycin-C (MMC) in trabeculectomy in people with Glaucoma, run by Aeon Astron Europe B.V. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Use of ologen Collagen Matrix in trabeculectomy (ologen) and Use of Mitomycin-C (MMC) in trabeculectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2011to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Glaucoma Associates of Texas
Dallas, Texas, 75231
Glaucoma Associates of New York
New York, New York, 10003
New York Eye and Ear Infirmary
New York, New York, 10003
Institue of Ophthalmology and Visual Science
Newark, New Jersey, 07103
Dean McGee Eye Institue
Oklahoma City, Oklahoma, 73104
Wills Eye Institue
Philadelphia, Pennsylvania, 19107
VoldVision-Holf Eye Clinic
Rogers, Arkansas, 72756
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Use of ologen Collagen Matrix in trabeculectomy (ologen), Use of Mitomycin-C (MMC) in trabeculectomy
- Keywords
- ologen collagen matrix, mitomycin-C, trabeculectomy, glaucoma, filtering surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ologen Collagen Matrix in trabeculectomy (ologen)Device
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.
Use of Mitomycin-C (MMC) in trabeculectomyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ologen Collagen Matrix | Experimental | When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva Receives: Device: Use of ologen Collagen Matrix in trabeculectomy (ologen) |
| Mitomycin-C (MMC) | Active comparator | When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva Receives: Drug: Use of Mitomycin-C (MMC) in trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At postoperative up to 24 months.
Secondary outcomes (1)
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.
Measured: At postoperative up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeon Astron Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The New York Eye & Ear Infirmary, Robert Ritch, MD, LLC.
- Responsible party
- Sponsor
- Investigators
- Robert Ritch, MD, Principal investigator, Robert Ritch, MD, LLC.Steven Sarkisian, MD, Study director, Dean McGee Eye InstituteRobert Fechtner, MD, Study director, Institute of Ophthalmology and Visual ScienceMichael Pro, MD, Study director, Wills Eye InstitueSteven Vold, MD, Study director, Boozman-Hof Eye ClinicAngelo Tanna, MD, Study director, Northwestern Memorial HospitalDavid Godfrey, MD, Study director, Glaucoma Associates of TexasPaul Sidoti, MD, Study director, New York Eye and Ear Infirmiry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440751
- Sponsor's protocol ID
- AAE-CT-USA-2010-02
- Acronym
- MCToCM
- Status last verified
- Oct 2017
- First submitted
- 14 Sep 2011
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PubMed 36912740Tanna 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.
PubMed 28034308
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
- ClinicalTrials.gov ID
- NCT01440751
- Acronym / sponsor ID
- MCToCM / AAE-CT-USA-2010-02
- Conditions
- Glaucoma
- Keywords
- ologen collagen matrix, mitomycin-C, trabeculectomy, glaucoma, filtering surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Aeon Astron Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- The New York Eye & Ear Infirmary, Robert Ritch, MD, LLC.
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ologen Collagen Matrix | Experimental | Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva |
| Mitomycin-C (MMC) | Active comparator | Drug: Use of Mitomycin-C (MMC) in trabeculectomyWhen performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ologen Collagen Matrix |
| Use of Mitomycin-C (MMC) in trabeculectomyAfter 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. | Drug | Mitomycin-C (MMC) |
Primary outcome
Intraocular pressure(IOP) reduction
Time frame: At postoperative up to 24 months.
"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.
1 secondary outcome
Postoperative complications and appearances
Time frame: At postoperative up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Derived from this study: PubMed 36912740Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
- Derived from this study: PubMed 28034308Tanna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ritch, MD principal investigator
Robert Ritch, MD, LLC.
Steven Sarkisian, MD study director
Dean McGee Eye Institute
Robert Fechtner, MD study director
Institute of Ophthalmology and Visual Science
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of ologen Collagen Matrix in trabeculectomy (ologen) and Use of Mitomycin-C (MMC) in trabeculectomy in people with Glaucoma, run by Aeon Astron Europe B.V. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure(IOP) reduction (time frame: At postoperative up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01440751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.