Open Angle GlaucomaPhase 3NCT00524758
Oculusgen (Ologen) Glaucoma MMC Control in Estonia
A Phase 3 study testing ologen (oculusgen) collagen matrix and MMC in Trabeculectomy in people with Open Angle Glaucoma and Angle Closure Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in Estonia.
Trial summary
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery. The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma
- What is being tested?
- ologen (oculusgen) collagen matrix and MMC in Trabeculectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEstonia
- Study dates
- Jul 2007to Oct 2011
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Max anti glaucoma medication failed,
Who cannot join
- Age less than 18, woman in pregnant, hemodialysis patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.
The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.
Read the detailed description
Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.
Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.
Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.
- Conditions
- Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma, Young Age Glaucoma, Neovascular Glaucoma, High Risk Patient
- Being tested
- ologen (oculusgen) collagen matrix, MMC in Trabeculectomy
- Keywords
- ologen, oculusgen, collagen matrix, trabeculectomy, filtering surgery, mitomycin-C, MMC, Aeon Astron
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ologen (oculusgen) collagen matrixDevice
Also called ologen collagen matrix, oculusgen collagen matrix
Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
MMC in TrabeculectomyDrug
MMC in Trabeculectomy
| Study group | Role | What they receive |
|---|---|---|
| Ologen in Trabeculectomy | Experimental | Ologen in Trabeculectomy Receives: Device: ologen (oculusgen) collagen matrix |
| MMC in Trabeculectomy | Active comparator | MMC in Trabeculectomy Receives: Drug: MMC in Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP <21mmHg without anti glaucoma medication
Measured: 180 days
Secondary outcomes (1)
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication
Measured: 180-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2011
- Study completionOct 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro Top & Mediking Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kuldar Kaljurand, MD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524758
- Sponsor's protocol ID
- oculusgen 2006-02-20
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2007
- Last updated
- 27 Jun 2017
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
- ClinicalTrials.gov ID
- NCT00524758
- Acronym / sponsor ID
- oculusgen 2006-02-20
- Conditions
- Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma, Young Age Glaucoma, Neovascular Glaucoma, High Risk Patient
- Keywords
- ologen, oculusgen, collagen matrix, trabeculectomy, filtering surgery, mitomycin-C, MMC, Aeon Astron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Sep 2007 (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.
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.
The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.
Detailed description
Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.
Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.
Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ologen in Trabeculectomy | Experimental | Device: ologen (oculusgen) collagen matrixOlogen in Trabeculectomy |
| MMC in Trabeculectomy | Active comparator | Drug: MMC in TrabeculectomyMMC in Trabeculectomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Max anti glaucoma medication failed,
Key exclusion criteria (1 listed)
- Age less than 18, woman in pregnant, hemodialysis patient
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 |
|---|---|---|
| ologen (oculusgen) collagen matrixAlso: ologen collagen matrix, oculusgen collagen matrixImplant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed. | Device | Ologen in Trabeculectomy |
| MMC in TrabeculectomyMMC in Trabeculectomy | Drug | MMC in Trabeculectomy |
Primary outcome
IOP <21mmHg without anti glaucoma medication
Time frame: 180 days
1 secondary outcome
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication
Time frame: 180-day
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 27 Jun 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.
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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.
Kuldar Kaljurand, MD principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ologen (oculusgen) collagen matrix and MMC in Trabeculectomy in people with Open Angle Glaucoma and Angle Closure Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in Estonia.
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 1 inclusion and 1 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 27 Jun 2017. 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 Estonia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
IOP <21mmHg without anti glaucoma medication (time frame: 180 days). 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 NCT00524758, 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 27 Jun 2017.