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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT00853073
First received: February 26, 2009
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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
Glaucoma
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 ]

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
Other Name: balanced salt solution

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Marlene Moster, MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT00853073     History of Changes
Other Study ID Numbers: 08-867
Study First Received: February 26, 2009
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Eye Diseases
Ocular Hypertension
Bevacizumab
Pharmaceutical Solutions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014