Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Grewal Eye Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Grewal Eye Institute
Information provided by:
Grewal Eye Institute
ClinicalTrials.gov Identifier:
NCT00468429
First received: April 30, 2007
Last updated: June 1, 2007
Last verified: June 2007
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00468429 History of Changes |
| Other Study ID Numbers: | GEI-00001 |
| Study First Received: | April 30, 2007 |
| Last Updated: | June 1, 2007 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Grewal Eye Institute:
|
Glaucoma Bevacizumab Glaucoma Filtration Surgery Mitomycin C Intraocular Pressure |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Mitomycin Bevacizumab Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Alkylating Agents Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013