The Effect of Bevacizumab on the Trabeculectomy

NCT ID: NCT01122966

Last Updated: 2010-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

Detailed Description

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Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.

Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.

Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.

The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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trabeculectomy

Subjects who have trabeculectomies with intraocular bevacizumab injection

Group Type OTHER

intraocular injections of bevacizumab

Intervention Type DRUG

intracameral and subconjunctival injections

Interventions

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intraocular injections of bevacizumab

intracameral and subconjunctival injections

Intervention Type DRUG

Other Intervention Names

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glaucoma filtering surgery

Eligibility Criteria

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Inclusion Criteria

* glaucoma patients who have trabeculectomy

Exclusion Criteria

* patients with the other ocular disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Changwon Kee, M.D., Ph.D

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Changwon Kee, M.D., Ph.D.

Role: CONTACT

82-2-3410-3564

Wool Suh, M.D.

Role: CONTACT

82-2-3410-3564

Facility Contacts

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Changwon Kee, M.D., Ph.D.

Role: primary

82-2-3410-3564

Wool Suh, M.D.

Role: backup

82-2-3410-3564

References

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Li Z, Van Bergen T, Van de Veire S, Van de Vel I, Moreau H, Dewerchin M, Maudgal PC, Zeyen T, Spileers W, Moons L, Stalmans I. Inhibition of vascular endothelial growth factor reduces scar formation after glaucoma filtration surgery. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5217-25. doi: 10.1167/iovs.08-2662. Epub 2009 May 27.

Reference Type BACKGROUND
PMID: 19474408 (View on PubMed)

Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.

Reference Type BACKGROUND
PMID: 18692246 (View on PubMed)

Other Identifiers

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2009-01-033

Identifier Type: -

Identifier Source: org_study_id

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