NCT00448929

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4.8 years

First QC Date

March 15, 2007

Last Update Submit

June 26, 2017

Conditions

Glaucoma

Keywords

GlaucomaCollagen matrixologenOculusGenTrabeculectomy

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.

    180 day

Study Arms (2)

Trabeculectomy with Oculusgen

EXPERIMENTAL
Device: OculusGen Biodegradable Collagen Matrix Implant

Trabeculectomy without Oculusgen or antifibrotic agents

NO INTERVENTION

Interventions

OculusGen Biodegradable Collagen Matrix ImplantDEVICE

Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Trabeculectomy with Oculusgen

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

L. V. Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500 034, India

Location

Related Publications (3)

  • 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.

    PMID: 17122118RESULT

  • 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

  • Park 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.

    PMID: 36912740DERIVED

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Anil Mandal, MD

    V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

IN(1)