NCT00406822

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

May 5, 2008

Status Verified

June 1, 2007

First QC Date

October 10, 2006

Last Update Submit

April 25, 2008

Conditions

Glaucoma

Keywords

Glaucomacollagen matrixOculusGentrabeculectomytissue engineering

Outcome Measures

Primary Outcomes (1)

  • the effectiveness via the reduction of IOP

    180 day

Secondary Outcomes (1)

  • the safety via the incidence of complications and adverse events.

    180day

Interventions

OculusGen Biodegradable Collagen Matrix ImplantDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital -Taipei Branch

Taipei, 10507, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 10937547RESULT

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Henry SL Chen, MD

    Chang Gung Memorial Hospital-Taipei Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2006

First Posted

December 4, 2006

Study Start

December 1, 2006

Last Updated

May 5, 2008

Record last verified: 2007-06

Locations

TW(1)