Open Angle GlaucomaPhase 4NCT00538590

Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

A Phase 4 study testing Collagen Matrix in Glaucoma Filtering Surgery and Mitomycin-C(MMC) and glaucoma filtering surgery in people with Open Angle Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery. 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?: Collagen Matrix in Glaucoma Filtering Surgery and Mitomycin-C(MMC) and glaucoma filtering surgery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: Jul 2007to Aug 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Open angle glaucoma
Maxima anti-glaucoma medication failed
Age>18
Able to complete the follow up

Who cannot join

Topical eye inflammation
Angle closure glaucoma
Deformity glaucoma
One eye glaucoma
Previous conjunctiva opened
Allergy to collagen

Trial locations and contacts

1 site in 1 country.

Germany1 site

Hospital of Universität Köln
Cologne, 50931

Other trials in Germany

About this study

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Read the detailed description

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Conditions: Open Angle Glaucoma
Being tested: Collagen Matrix in Glaucoma Filtering Surgery, Mitomycin-C(MMC) and glaucoma filtering surgery
Keywords: ologen, collagen matrix, glaucoma, trabeculectomy, Mitomycin-C
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.

Collagen Matrix in Glaucoma Filtering SurgeryDevice
Also called ologen™
Collagen Matrix implantation in Glaucoma Filtering Surgery
Mitomycin-C(MMC) and glaucoma filtering surgeryDrug
Also called Mitomycin C
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Study groups in NCT00538590
Study group	Role	What they receive
MITOMYCIN-C	Active comparator	Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C. Receives: Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
ologen (Oculusgen)	Experimental	20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. Receives: Device: Collagen Matrix in Glaucoma Filtering Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Intraocular Pressure Change
Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Measured: 360 days
Postoperative Intraocular Pressure Change
Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Measured: 180 days
Postoperative Intraocular Pressure Change
Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Measured: 90 days
Postoperative Intraocular Pressure Change
Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Measured: 30 days

Secondary outcomes (1)

Complications
Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.
Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Aug 2010

First posted2 Oct 2007 (estimated)
Study startJul 2007
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00538590
Sponsor's protocol ID: ologen-Koln
Status last verified: Apr 2012
First submitted: 29 Sep 2007
Last updated: 25 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
ClinicalTrials.gov ID: NCT00538590
Acronym / sponsor ID: ologen-Koln
Conditions: Open Angle Glaucoma
Keywords: ologen, collagen matrix, glaucoma, trabeculectomy, Mitomycin-C
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 2 Oct 2007 (estimated)
Results: Posted 25 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MITOMYCIN-C	Active comparator	Drug: Mitomycin-C(MMC) and glaucoma filtering surgeryFollowing ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
ologen (Oculusgen)	Experimental	Device: Collagen Matrix in Glaucoma Filtering Surgery20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the 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)

Open angle glaucoma
Maxima anti-glaucoma medication failed
Age>18
Able to complete the follow up

Key exclusion criteria (6 listed)

Topical eye inflammation
Angle closure glaucoma
Deformity glaucoma
One eye glaucoma
Previous conjunctiva opened

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
Collagen Matrix in Glaucoma Filtering SurgeryAlso: ologen™Collagen Matrix implantation in Glaucoma Filtering Surgery	Device	ologen (Oculusgen)
Mitomycin-C(MMC) and glaucoma filtering surgeryAlso: Mitomycin CIf mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.	Drug	MITOMYCIN-C

Primary outcome

Postoperative Intraocular Pressure Change
Time frame: 360 days
Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Postoperative Intraocular Pressure Change
Time frame: 180 days
Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Postoperative Intraocular Pressure Change
Time frame: 90 days
Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Postoperative Intraocular Pressure Change
Time frame: 30 days
Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

1 secondary outcome

Complications
Time frame: 360 days

Results and safety

Results posted to the registry on 25 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MITOMYCIN-C	10	9
Ologen (Oculusgen)	10	10

Primary outcome: Postoperative Intraocular Pressure Change

Time frame: 360 days. Mean (Standard Deviation). Unit: mm Hg

Measure	MITOMYCIN-C n = 9	Ologen (Oculusgen) n = 10
Value	-11.3 (8.7)	-11.6 (9.9)

MITOMYCIN-C vs Ologen (Oculusgen): p = 0.95, ANOVA

Primary outcome: Postoperative Intraocular Pressure Change

Time frame: 180 days. Mean (Standard Deviation). Unit: mm Hg

Measure	MITOMYCIN-C n = 10	Ologen (Oculusgen) n = 10
Value	-11.8 (6.1)	-11.8 (11.2)

MITOMYCIN-C vs Ologen (Oculusgen): p = 1.00, ANOVA

Primary outcome: Postoperative Intraocular Pressure Change

Time frame: 90 days. Mean (Standard Deviation). Unit: mm Hg

Measure	MITOMYCIN-C n = 10	Ologen (Oculusgen) n = 10
Value	-10.9 (5.8)	-14.1 (10.1)

MITOMYCIN-C vs Ologen (Oculusgen): p = 0.40, ANOVA

Primary outcome: Postoperative Intraocular Pressure Change

Time frame: 30 days. Mean (Standard Deviation). Unit: mm Hg

Measure	MITOMYCIN-C n = 10	Ologen (Oculusgen) n = 10
Value	-13.3 (6.4)	-12.9 (8.6)

MITOMYCIN-C vs Ologen (Oculusgen): p = 0.91, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MITOMYCIN-C	1 of 10 (10%)	0 of 10 (0%)	Not reported
Ologen (Oculusgen)	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Stat Methods and limited sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Publication on EyeLink provided by the sponsor.

Related trials for Open Angle Glaucoma

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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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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, Ph. D, MD principal investigator

Universität Köln

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 25 Apr 2012. 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.

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?

Yes. Results are posted in the registry (first posted 25 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Postoperative Intraocular Pressure Change (time frame: 360 days). The study lists 4 primary outcomes in all. 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 NCT00538590, 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 25 Apr 2012.