GlaucomaPhase 3NCT00448929
Ologen (OculusGen)-Glaucoma Case Control Trial in India
A Phase 3 study testing OculusGen Biodegradable Collagen Matrix Implant in people with Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in India.
Trial summary
The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- OculusGen Biodegradable Collagen Matrix Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jan 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 years or over.
- No previous intraocular operative surgery
- Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
- Subject willing to sign informed consent form.
Who cannot join
- Known allergic reaction to porcine collagen.
- Subject is on warfarin and discontinuation is not recommended.
- Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
- Participation in an investigational study during the 30 days proceeding trabeculectomy.
- Ocular infection within 14 days prior to trabeculectomy.
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant
The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.
Read the detailed description
- Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
- Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics.
- Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.
- Conditions
- Glaucoma
- Being tested
- OculusGen Biodegradable Collagen Matrix Implant
- Keywords
- Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OculusGen Biodegradable Collagen Matrix ImplantDevice
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy with Oculusgen | Experimental | Not described Receives: Device: OculusGen Biodegradable Collagen Matrix Implant |
| Trabeculectomy without Oculusgen or antifibrotic agents | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness via the reduction of IOP
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 posted19 Mar 2007 (estimated)
- Study startJan 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 (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro Top & Mediking Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anil Mandal, MD, Principal investigator, V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448929
- Sponsor's protocol ID
- Mediking 0702
- Other IDs
- OculusGen-2006-03-20
- Status last verified
- Jun 2017
- First submitted
- 15 Mar 2007
- Last updated
- 27 Jun 2017
- Results posted
- No
Publications
Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378.
PubMed 17122118Hsu 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 10937547Park 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
- Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant
- ClinicalTrials.gov ID
- NCT00448929
- Acronym / sponsor ID
- Mediking 0702
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2007 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Mar 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 compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.
Detailed description
- Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
- Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics.
- Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy with Oculusgen | Experimental | Device: OculusGen Biodegradable Collagen Matrix Implant |
| Trabeculectomy without Oculusgen or antifibrotic agents | No intervention | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 30 years or over.
- No previous intraocular operative surgery
- Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
Key exclusion criteria (6 listed)
- Known allergic reaction to porcine collagen.
- Subject is on warfarin and discontinuation is not recommended.
- Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
- Participation in an investigational study during the 30 days proceeding trabeculectomy.
- Ocular infection within 14 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 |
|---|---|---|
| OculusGen Biodegradable Collagen Matrix ImplantTrabeculectomy with OculusGen Biodegradable Collagen Matrix Implant | Device | Trabeculectomy with Oculusgen |
Primary outcome
the effectiveness via the reduction of IOP
Time frame: 180 day
1 secondary outcome
the safety via the incidence of complications and adverse events.
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.
- Results publication: PubMed 17122118Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378.
- 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.
- 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.
Anil Mandal, MD principal investigator
V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
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 OculusGen Biodegradable Collagen Matrix Implant in people with Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in India.
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 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 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 India. 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?
the effectiveness via the reduction of IOP (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 NCT00448929, which also lists 3 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 27 Jun 2017.