Open-angle GlaucomaNCT01174420
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
A study testing Use of ologen Collagen Matrix in trabeculectomy and Use of Mitomycin-C in trabeculectomy in people with Open-angle Glaucoma, run by Aeon Astron Europe B.V. at 1 site in Germany.
Trial summary
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Use of ologen Collagen Matrix in trabeculectomy and Use of Mitomycin-C in trabeculectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Nov 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over
- Uncontrolled open-angle glaucoma
- Subject is willing to sign informed consent
- Subject is able and willing to complete post-operative follow-up requirements
Who cannot join
- Inflammatory eye diseases
- Angle-closure glaucoma
- Secondary glaucoma with anatomical malformations of the eye
- Subjects having single functional eye
- Previous conjunctival surgery
- Known allergic reactions to ingredients of ologen Collagen Matrix
Show all 9Show fewer
- Excessive myopia (axial length (AL)> 27 mm or more than -10 diopters)
- Previous vitrectomy eye surgery
- Subjects do not consent to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
The University Hospital of Cologne
Cologne, 50937
Thomas Dietlein, MD, +49-221-478-5862 ext. 4300, thomas.dietlein@uk-koeln.de
Thomas Dietlein, MD
About this study
Official title: A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
Read the detailed description
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.
The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
- Conditions
- Open-angle Glaucoma
- Being tested
- Use of ologen Collagen Matrix in trabeculectomy, Use of Mitomycin-C in trabeculectomy
- Keywords
- ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery
- Medical subject headings
- Glaucoma, Open-Angle, 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 trabeculectomyDevice
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
Use of Mitomycin-C in trabeculectomyDrug
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
| Study group | Role | What they receive |
|---|---|---|
| ologen Collagen Matrix | Experimental | Not described Receives: Device: Use of ologen Collagen Matrix in trabeculectomy |
| Mitomycin-C (MMC) | Active comparator | Not described Receives: Drug: Use of Mitomycin-C in trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) reduction
Measured: 6 months
Secondary outcomes (1)
Incidence of complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open-angle 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aeon Astron Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Dietlein, MD, Principal investigator, Department of Ophthalmology, University of Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174420
- Sponsor's protocol ID
- AAE-CT-DEU-2009-01
- Status last verified
- May 2011
- First submitted
- 2 Aug 2010
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- 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 36912740
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
- ClinicalTrials.gov ID
- NCT01174420
- Acronym / sponsor ID
- AAE-CT-DEU-2009-01
- Conditions
- Open-angle Glaucoma
- Keywords
- ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aeon Astron Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 3 Aug 2010 (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 aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
Detailed description
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.
The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
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 |
| Mitomycin-C (MMC) | Active comparator | Drug: Use of Mitomycin-C in trabeculectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or over
- Uncontrolled open-angle glaucoma
- Subject is willing to sign informed consent
- Subject is able and willing to complete post-operative follow-up requirements
Key exclusion criteria (9 listed)
- Inflammatory eye diseases
- Angle-closure glaucoma
- Secondary glaucoma with anatomical malformations of the eye
- Subjects having single functional eye
- Previous conjunctival surgery
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 trabeculectomyAfter trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing | Device | ologen Collagen Matrix |
| Use of Mitomycin-C in trabeculectomyAfter creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution. | Drug | Mitomycin-C (MMC) |
Primary outcome
Intraocular pressure (IOP) reduction
Time frame: 6 months
1 secondary outcome
Incidence of complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- 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.
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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.
Thomas Dietlein, MD principal investigator
Department of Ophthalmology, University of Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ologen Collagen Matrix in trabeculectomy and Use of Mitomycin-C in trabeculectomy in people with Open-angle Glaucoma, run by Aeon Astron Europe B.V. at 1 site in Germany.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Dietlein, MD (+49-221-478-5862 ext. 4300, thomas.dietlein@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) reduction (time frame: 6 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 NCT01174420, which also lists 1 linked publication.
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 9 May 2011.