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OpenTrials
Completed

NCT Number: NCT00853073

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

Balanced Salt Solution

Other

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

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 6 months

    mmHg (millimeters of mercury)

Secondary outcomes

  1. Number of Participants With Surgical Success

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

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

Acronym: Avastin

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2009
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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