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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: |
NCT00540930 |
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Date of registration:
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05/10/2007 |
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Primary sponsor: |
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Public title:
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Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy
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Scientific title:
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A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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400 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00540930 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Carol L Shields, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wills Eye Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >18 years
- new diagnosis of choroidal melanoma
- scheduled for plaque radiotherapy at Wills Eye Health System
Exclusion Criteria:
- Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic
maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
- prior retinal detachment
- media opacities precluding accurate OCT imaging
- history of glaucoma
- pregnancy
- age <18 years.
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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Radiation Maculopathy
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Radiation Retinopathy
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Uveal Melanoma
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Intervention(s)
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Drug: Ranibizumab
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Primary Outcome(s)
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Presence or absence of optical coherence (OCT) evidence of macular edema.
[Time Frame: 4 months]
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Secondary Outcome(s)
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Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.
[Time Frame: 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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