Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery
Comparative Study of the Safety and Effectiveness Between Off-Label Subconjunctival Bevacizumab and Mitomycin C in Glaucoma Filtering Surgery.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 2, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 4, 2007
June 1, 2007
April 30, 2007
June 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IOP < 18mmHg without anti- glaucoma medications at 6 months follow up after surgery or at least a 20% reduction from baseline IOP.
6 months
Secondary Outcomes (1)
adverse reaction to bevacizumab at site of injection
6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grewal Eye Institute
Chandigarh, Chandigarh, 160009, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2007
First Posted
May 2, 2007
Study Start
May 1, 2007
Study Completion
December 1, 2007
Last Updated
June 4, 2007
Record last verified: 2007-06