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Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery

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ClinicalTrials.gov Identifier: NCT00468429
Recruitment Status : Unknown
Verified June 2007 by Grewal Eye Institute.
Recruitment status was:  Recruiting
First Posted : May 2, 2007
Last Update Posted : June 4, 2007
Sponsor:
Information provided by:
Grewal Eye Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Drug: Subconjunctival Bevacizumab Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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.
Study Start Date : May 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. 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 :
  1. adverse reaction to bevacizumab at site of injection [ Time Frame: 6 months ]


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

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

ClinicalTrials.gov Identifier: NCT00468429     History of Changes
Other Study ID Numbers: GEI-00001
First Posted: May 2, 2007    Key Record Dates
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