NCT00472810

Brief Summary

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Trial Health

80
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

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

May 11, 2007

Last Update Submit

October 6, 2011

Conditions

GlaucomaTrabeculectomy

Keywords

GlaucomaCollagen matrixologenOculusGenAntifibroticTrabeculectomyanti scarringtissue engineeringhigh risk patient for trabeculectomyAeon Astron

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)

1

EXPERIMENTAL

20 patients will be recruited according to the enrollment acceptance criteria.Randomisation is performed using a sealed envelope system, where 40 shuffled envelopes designating the surgery to either trabeculectomy with mitomycin-C (MMC) and trabeculectomy with ologen™ Collagen matrix must be open before surgery. Then, patients are allocated and trabeculectomy is performed.If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

Device: ologen collagen matrix in glaucoma filtering surgery

2

ACTIVE COMPARATOR

Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C. Randomisation is performed. Then, trabeculectomy is performed

Drug: MMC in glaucoma filtering surgery

Interventions

ologen collagen matrix in glaucoma filtering surgeryDEVICE

If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

1
MMC in glaucoma filtering surgeryDRUG

If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Also known as: Mitomycin C
2

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or over.
  • 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 mitomycin-C or Bovine collagen.
  • Subject is on warfarin and discontinuation is not recommended.
  • Normal tension glaucoma.
  • Participation in an investigational study during the 30 days preceding 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)

RMC & Allied Hospital

Rawalpindi, Punjab Province, Pakistan

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

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Syed Imtiaz Ali, Professor

    RMC & Allied Hospital

    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

May 11, 2007

First Posted

May 14, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

PA(1)