Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

NCT ID: NCT00853073

Last Updated: 2018-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Detailed Description

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To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure

balanced salt solution

patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.

Group Type PLACEBO_COMPARATOR

balanced salt solution

Intervention Type OTHER

0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Interventions

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bevacizumab

1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure

Intervention Type DRUG

balanced salt solution

0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Intervention Type OTHER

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* require glaucoma bleb needle revision with Mitomycin-C

Exclusion Criteria

* pregnant, nursing, or not using adequate contraception
* other glaucoma eye surgery involving tube shunts
* prior retinal detachments surgery with scleral buckle
* infection, inflammation, or any abnormality preventing eye pressure measurement
* enrolled in another investigational study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Marlene Moster, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlene R Moster, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye

Locations

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Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Tai TY, Moster MR, Pro MJ, Myers JS, Katz LJ. Needle bleb revision with bevacizumab and mitomycin C compared with mitomycin C alone for failing filtration blebs. J Glaucoma. 2015 Apr-May;24(4):311-5. doi: 10.1097/IJG.0b013e31829f9bd3.

Reference Type RESULT
PMID: 25826644 (View on PubMed)

Other Identifiers

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08-867

Identifier Type: -

Identifier Source: org_study_id

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