OculusGen-Glaucoma Historical Control Study in Taiwan | NCT00406822

Studies
OculusGen-Glaucoma Historical Control Study in Taiwan

NCT00406822

Sponsor

Pro Top & Mediking Company Limited

Status

Terminated

Last Update Posted

May 5, 2008Estimated

Enrollment

48Estimated

Phase

Phase 3

Conditions

Glaucoma

Interventions

OculusGen Biodegradable Collagen Matrix Implant

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to the change of supplier and sponsor

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2008

Last Update Posted Date

May 5, 2008Estimated

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Name	Type	Description	Arm Group Labels	Other Names
OculusGen Biodegradable Collagen Matrix Implant	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the effectiveness via the reduction of IOP		180 day

Secondary Outcomes

Measure	Description	Time Frame
the safety via the incidence of complications and adverse events.		180day

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry SL Chen, MD	Chang Gung Memorial Hospital-Taipei Branch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital -Taipei Branch		Taipei		10507	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10937547	Result	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases