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

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ClinicalTrials.gov Identifier: NCT00853073
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : March 12, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: bevacizumab Other: balanced salt solution Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : February 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 6 months ]
    mmHg (millimeters of mercury)


Secondary Outcome Measures :
  1. Surgical Success Rates [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853073


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

Publications of Results:
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
ClinicalTrials.gov Identifier: NCT00853073     History of Changes
Other Study ID Numbers: 08-867
First Posted: February 27, 2009    Key Record Dates
Results First Posted: March 12, 2015
Last Update Posted: April 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marlene Moster, MD, Wills Eye:
failing blebs
failing express shunt
avastin
bevacizumab
glaucoma
prior trabeculectomy
Express shunt placed under a scleral flap
subsequent filtration failure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents