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Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Grewal Eye Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468429
First Posted: May 2, 2007
Last Update Posted: June 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Grewal Eye Institute
  Purpose
This study analyzes the safety and efficacy of off-label Subconjunctival Injection of bevacizumab (Avastin) versus 0.02% mitomycin C (MMC) for preventing bleb failure following glaucoma filtration surgery.

Condition Intervention Phase
Glaucoma Drug: Subconjunctival Bevacizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparative Study of the Safety and Effectiveness Between Off-Label Subconjunctival Bevacizumab and Mitomycin C in Glaucoma Filtering Surgery.

Resource links provided by NLM:


Further study details as provided by Grewal Eye Institute:

Primary Outcome Measures:
  • IOP < 18mmHg without anti- glaucoma medications at 6 months follow up after surgery or at least a 20% reduction from baseline IOP. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • adverse reaction to bevacizumab at site of injection [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40 years or over.
  2. Patient with uncontrolled intraocular pressure on maximum tolerated medical therapy (both primary open angle and primary angle closure glaucoma), requiring trabeculectomy.
  3. Indications for surgery are based on our own practice patterns: (1) IOP values that are associated with high probability of glaucoma progression and (2) deterioration of the visual field or changes of the optic disk that is compatible with progressive glaucomatous damage, as judged by the examining physician.
  4. No history of prior surgical procedure like trabeculectomy, cataract surgery, posterior segment surgery etc.
  5. Subject able and willing to cooperate with investigation plan.
  6. Subject able and willing to complete postoperative follow-up requirements.
  7. Subject willing to sign informed consent form.

Exclusion Criteria:

  1. Known allergic reaction to mitomycin-C/ bevacizumab.
  2. Subject is on warfarin and discontinuation is not recommended.
  3. Normal tension glaucoma.
  4. Participation in an investigational study during the 30 days preceding trabeculectomy
  5. Patients who had undergone major surgery utpo 28 days before.
  6. Ocular infection within 14 days prior to trabeculectomy.
  7. Pregnant or breast-feeding women.
  8. Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications
  Contacts and Locations
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): NCT00468429


Contacts
Contact: Rajeev Jain, MD +91-172-5056969 rajeevjain74@gmail.com
Contact: Dilraj S Grewal, MBBS +91-172-5056969 dilraj@gmail.com

Locations
India
Grewal Eye Institute Recruiting
Chandigarh, India, 160009
Contact: Dilraj S Grewal, MBBS    +91-172-5056969    dilraj@gmail.com   
Principal Investigator: Dilraj S Grewal, MBBS         
Sponsors and Collaborators
Grewal Eye Institute
Investigators
Principal Investigator: Rajeev Jain, MD Grewal Eye Institute
Study Chair: SPS Grewal, MD Grewal Eye Institute
Study Director: Gagandeep S Brar, MD Grewal Eye Institute
Study Director: Dilraj S Grewal, MBBS Grewal Eye Institute
  More Information

ClinicalTrials.gov Identifier: NCT00468429     History of Changes
Other Study ID Numbers: GEI-00001
First Submitted: April 30, 2007
First Posted: May 2, 2007
Last Update Posted: June 4, 2007
Last Verified: June 2007

Keywords provided by Grewal Eye Institute:
Glaucoma
Bevacizumab
Glaucoma Filtration Surgery
Mitomycin C
Intraocular Pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Bevacizumab
Mitomycins
Mitomycin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors