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

This study has been completed.
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye Identifier:
First received: February 26, 2009
Last updated: March 11, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Drug: bevacizumab
Other: balanced salt solution
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

Resource links provided by NLM:

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmHg (milimeters of mercury)

Secondary Outcome Measures:
  • Improvement in Filtering Blebs Morphology [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: bevacizumab
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
Other Name: Avastin
Placebo Comparator: 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.
Other: balanced salt solution
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00853073

United States, Pennsylvania
Wills Eye Institute, Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Principal Investigator: Marlene R Moster, MD Wills Eye
  More Information

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.

Responsible Party: Marlene Moster, MD, Principal Investigator, Wills Eye Identifier: NCT00853073     History of Changes
Other Study ID Numbers: 08-867
Study First Received: February 26, 2009
Results First Received: January 30, 2015
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
failing blebs
failing express shunt
prior trabeculectomy
Express shunt placed under a scleral flap
subsequent filtration failure

Additional relevant MeSH terms:
Eye Diseases
Ocular Hypertension
Pharmaceutical Solutions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2015