Back to resultsOculusGen-Glaucoma Historical Control Study in Taiwan
Primary Purpose
Glaucoma
Status
Terminated
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
OculusGen Biodegradable Collagen Matrix Implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, collagen matrix, OculusGen, trabeculectomy, tissue engineering
Eligibility Criteria
Subject inclusion criteria:
- Age 18 years or over.
- At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- 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.
Subject exclusion criteria:
- Have allergic reactions to collagen
- Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
- Normal tension glaucoma patient
- Subject has one eye received OculusGen™ implantation
- Subject who been diagnosed infection with the operation eye
- Subject with anterior chamber abnormality
- Subject with steroid glaucoma
Sites / Locations
- Chang Gung Memorial Hospital -Taipei Branch
Outcomes
Primary Outcome Measures
the effectiveness via the reduction of IOP
Secondary Outcome Measures
the safety via the incidence of complications and adverse events.
Full Information
NCT ID
NCT00406822
First Posted
October 10, 2006
Last Updated
April 25, 2008
Sponsor
Pro Top & Mediking Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00406822
Brief Title
OculusGen-Glaucoma Historical Control Study in Taiwan
Official Title
Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to the change of supplier and sponsor
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pro Top & Mediking Company Limited
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, collagen matrix, OculusGen, trabeculectomy, tissue engineering
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
OculusGen Biodegradable Collagen Matrix Implant
Primary Outcome Measure Information:
Title
the effectiveness via the reduction of IOP
Time Frame
180 day
Secondary Outcome Measure Information:
Title
the safety via the incidence of complications and adverse events.
Time Frame
180day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject inclusion criteria:
Age 18 years or over.
At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
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.
Subject exclusion criteria:
Have allergic reactions to collagen
Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
Normal tension glaucoma patient
Subject has one eye received OculusGen™ implantation
Subject who been diagnosed infection with the operation eye
Subject with anterior chamber abnormality
Subject with steroid glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry SL Chen, MD
Organizational Affiliation
Chang Gung Memorial Hospital-Taipei Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital -Taipei Branch
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
10937547
Citation
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.
Results Reference
result
Learn more about this trial
OculusGen-Glaucoma Historical Control Study in Taiwan
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