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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma | Drug: Subconjunctival Bevacizumab | Phase 4 |

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 |

- 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 ]
- adverse reaction to bevacizumab at site of injection [ Time Frame: 6 months ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 40 years or over.
- Patient with uncontrolled intraocular pressure on maximum tolerated medical therapy (both primary open angle and primary angle closure glaucoma), requiring trabeculectomy.
- 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.
- No history of prior surgical procedure like trabeculectomy, cataract surgery, posterior segment surgery etc.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
- Subject willing to sign informed consent form.
Exclusion Criteria:
- Known allergic reaction to mitomycin-C/ bevacizumab.
- Subject is on warfarin and discontinuation is not recommended.
- Normal tension glaucoma.
- Participation in an investigational study during the 30 days preceding trabeculectomy
- Patients who had undergone major surgery utpo 28 days before.
- Ocular infection within 14 days prior to trabeculectomy.
- Pregnant or breast-feeding women.
- Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications

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