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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: |
NCT01453920 |
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Date of registration:
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13/10/2011 |
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Primary sponsor: |
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Public title:
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Wet AMD Recurrence Rate in Patients Stable on Three Month Ranibizumab Dosing
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Scientific title:
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Choroidal Neovascular Membrane Recurrence Rate in Wet AMD Patients Stable on Three Month Ranibizumab Dosing |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01453920 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Michael H Brent, MD FRCSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Toronto Western Hospital, University Health Network |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 50 years or more
- Active primary or recurrent choroidal neovascularization secondary to AMD in the
study eye, currently stable on an 'every three month' treatment regimen (established
using a treat and extend dosing protocol)
- Best-corrected visual acuity of Counting Fingers or better (Snellen equivalent) in
the study eye
- All IVFA lesion types and lesion sizes
- One eye per subject (the "study eye"). If both eyes are eligible, the one with better
VA will be selected unless, for medical reasons, the other is more appropriate
Exclusion Criteria:
- Treatment of the current choroidal neovascular membrane with verteporfin photodynamic
therapy (PDT), external-beam radiation therapy, transpupillary thermotherapy, or
subfoveal laser photocoagulation (or juxtafoveal or extrafoveal laser
photocoagulation
- History of vitrectomy surgery in the study eye
- Individuals with choroidal neovascularization from causes other than AMD
Age minimum:
50 Years
Age maximum:
N/A
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: Ranibizumab
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Primary Outcome(s)
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Prevalence of CNVM recurrence
[Time Frame: 6 months]
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Secondary Outcome(s)
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Central Retinal Thickness measurement on SDOCT
[Time Frame: 6 months]
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Incidence of ocular and systemic adverse events
[Time Frame: 6 months]
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Mean change in VA between baseline
[Time Frame: 6 months]
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Number of Ranibizumab injections
[Time Frame: 6 months]
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Patient's sensitivity in subjectively detecting CNVM recurrence (gold standard for comparison, clinical presentation including DFEx, OCT, +/- IVFA)
[Time Frame: 6 months]
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Presence of subretinal and/or intraretinal fluid on SDOCT
[Time Frame: 6 months]
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Proportion of patients losing > 15 letters (3 lines) from baseline
[Time Frame: 6 months]
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Secondary ID(s)
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11-0686-AE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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