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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 October 2017 |
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Main ID: |
NCT00661479 |
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Date of registration:
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29/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
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Scientific title:
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Date of first enrolment:
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July 2008 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00661479 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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Germany
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Portugal
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Retinitis Pigmentosa in both eyes
- Visual acuity between 20/40 to count fingers
Exclusion Criteria:
- Growth of new blood vessels in the eye
- Any intraocular surgery or laser in either eye in the last 6 months prior to Screening
visit or between the Screening visit and Day 1
- Any ocular disease that can interfere with diagnosis and or assessment of disease
progression
- Significant near-sightedness
- HIV
- Female patients who are pregnant, nursing, or planning pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Other: Sham (no implant)
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Drug: 400 µg Brimonidine Tartrate Implant
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Drug: 100 µg Brimonidine Tartrate Implant
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Drug: 200 µg Brimonidine Tartrate Implant
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Primary Outcome(s)
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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
[Time Frame: Baseline, Month 6]
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Secondary Outcome(s)
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Change From Baseline in Contrast Sensitivity in the Study Eye
[Time Frame: Baseline, Month 6]
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Secondary ID(s)
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190342-028D
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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