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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
balanced salt solution
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Institute, Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bevacizumab

balanced salt solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)
mmHg (millimeters of mercury)

Secondary Outcome Measures

Number of Participants With Surgical Success
Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.

Full Information

First Posted
February 26, 2009
Last Updated
June 7, 2018
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT00853073
Brief Title
Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
Acronym
Avastin
Official Title
Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
balanced salt solution
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
Intervention Type
Other
Intervention Name(s)
balanced salt solution
Intervention Description
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
mmHg (millimeters of mercury)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Surgical Success
Description
Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene R Moster, MD
Organizational Affiliation
Wills Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute, Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25826644
Citation
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.
Results Reference
result

Learn more about this trial

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

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