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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT02901236 |
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Date of registration:
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31/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma
AvastinvsMMC |
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Scientific title:
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Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma: A Randomized Pilot Trial. |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02901236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Contacts
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Name:
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Gerassimos Kopsinis, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Athens Vision Eye Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients
- primary or secondary open angle or angle closure glaucoma
- preoperative intraocular pressure > 21 mmHg on maximally tolerated medical therapy at
least on 2 occasions prior to randomization
- ability to attend regular follow-up
Exclusion Criteria:
- age (< 18 years)
- pregnancy
- severe ocular surface disease
- need for combined phacotrabeculectomy
- uveitic or neovascular glaucoma
- any prior intraocular surgery except for uncomplicated phacoemulsification
- a history of a systemic thromboembolic event within 6 months before surgery
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glaucoma
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Intervention(s)
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Procedure: Standard Guarded Trabeculectomy
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Drug: Bevacizumab
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Drug: Mitomycin C
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Primary Outcome(s)
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Intraocular Pressure
[Time Frame: 1 year after the intervention]
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Secondary Outcome(s)
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Rate of Surgical Success (Survival of Surgical Procedure)
[Time Frame: 1 year after the intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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