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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00556348 |
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Date of registration:
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09/11/2007 |
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Primary sponsor: |
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Public title:
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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
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Scientific title:
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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00556348 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Joao J Nassaralla, Jr |
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Address:
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Telephone:
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Email:
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Affiliation:
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UnB and IOG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM
following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or
Lucentis which is FDA approved.
- Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with
CNVM.
- Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant
macular oedema (CSME) etc. that affects vision and does not respond adequately to
usual treatment methods.
- Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
Exclusion Criteria:
- Patients with poor compliance
- Patients with uncontrolled diabetes and hypertension or any other medical condition
that increase the risk of complications like recent history of Stroke or myocardial
infraction (< one year). (Physician clearance was obtained for all patients).
- Patients who had undergone major surgery 28 days before, were excluded from the study
and it was also suspended prior to elective surgery.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Age Related Macular Degeneration
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Intervention(s)
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Drug: bevacizumab
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Primary Outcome(s)
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Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP
[Time Frame: Yes]
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Secondary Outcome(s)
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Ocular side effects (infection, RD, IOP rise, cataract)
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Secondary ID(s)
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JN-02-2007-ARVO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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