GlaucomasPhase 3NCT00478790
Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
A Phase 3 study testing ologen™ Collagen matrix implantation in glaucoma filtering surgery in people with Glaucomas and Pterygium, run by Pro Top & Mediking Company Limited at 1 site in China.
Trial summary
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ologen™ Collagen matrix implantation in glaucoma filtering surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over
- Patient able to cooperate with study procedures and able to perform tests reliably
- Patient willing to sign informed consent
- Patient able and willing to complete postoperative follow-up requirements
- Glaucoma：one/both eyes are affected by glaucoma
- Pterygium： patient with pterygium
Who cannot join
- Known allergic reactions to collagen
Trial locations and contacts
1 site in 1 country.
Qiang Wu, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai sixth People's Hospital
Shanghai, 200233
Qiang Wu, MD, +86 21-64369181 ext. 8367, wyan559@hotmail.com
Qiang Wu, MD
About this study
Official title: Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.
Read the detailed description
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).
- Being tested
- ologen™ Collagen matrix implantation in glaucoma filtering surgery
- Keywords
- Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, ologen, Aeon Astron
- Medical subject headings
- Glaucoma, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ologen™ Collagen matrix implantation in glaucoma filtering surgeryDevice
Also called Oculusgen™ (ologen™)
ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ologen™ collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. After operation with ologen™ Collagen Matrix, anti-inflammatory eye-drops will be prescribed Receives: Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
Measured: 180 day
Secondary outcomes (1)
the safety via the incidence of complications and adverse events.
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 posted25 May 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2011 (estimated)
- Study completionOct 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 GlaucomasStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro Top & Mediking Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qiang Wu, MD, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478790
- Sponsor's protocol ID
- Mediking 0705
- Other IDs
- Mediking 0503
- Status last verified
- Jun 2008
- First submitted
- 24 May 2007
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
PubMed 10937547
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
- ClinicalTrials.gov ID
- NCT00478790
- Acronym / sponsor ID
- Mediking 0705
- Keywords
- Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 25 May 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.
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.
Detailed description
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ologen™ Collagen matrix implantation in glaucoma filtering surgeryologen™ collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. After operation with ologen™ Collagen Matrix, anti-inflammatory eye-drops will be prescribed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or over
- Patient able to cooperate with study procedures and able to perform tests reliably
- Patient willing to sign informed consent
- Patient able and willing to complete postoperative follow-up requirements
- Glaucoma：one/both eyes are affected by glaucoma
Key exclusion criteria (1 listed)
- Known allergic reactions to collagen
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™ Collagen matrix implantation in glaucoma filtering surgeryAlso: Oculusgen™ (ologen™)ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. | Device | 1 |
Primary outcome
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
Time frame: 180 day
1 secondary outcome
the safety via the incidence of complications and adverse events.
Time frame: 180 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Results publication: PubMed 10937547Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
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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.
Qiang Wu, MD contact
Qiang Wu, MD principal investigator
Shanghai 6th People's Hospital
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™ Collagen matrix implantation in glaucoma filtering surgery in people with Glaucomas and Pterygium, run by Pro Top & Mediking Company Limited at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wu, MD (+86 21-64369181 ext. 8367), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence (time frame: 180 day). 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 NCT00478790, 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 7 Oct 2011.