Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Design

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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

Arms and Interventions

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Outcome Measures

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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 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00468429 History of Changes
Other Study ID Numbers:	GEI-00001
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