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

Glaucoma Clinical Trial

— Avastin  

Official title:

Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853073
• Other study ID #: 08-867
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

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

Locations

Country	Name	City	State
United States	Wills Eye Institute, Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tai TY, Pro M, Katz LJ, Myers J, Spaeth GL, Moster MR. Needle Bleb Revision with Bevacizumab for Failing Filtration Blebs. ARVO E-abstract 629/A473 2010.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	mmHg (millimeters of mercury)	6 months
Secondary	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.	6 months