A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
NCT ID: NCT01941082
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2013-12-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A: RO6867461
Single doses
RO6867461
Single or multiple ascending dose by intravitreal injection
Part B: RO6867461
Multiple doses
RO6867461
Single or multiple ascending dose by intravitreal injection
Interventions
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RO6867461
Single or multiple ascending dose by intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* Patients with age-related macular degeneration (AMD)
* Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive
* Evidence of leakage due to choroidal neovascularization (CNV)
Exclusion Criteria
* Known hypersensitivity to ranibizumab, fluorescein, indocyanin green (ICG) or any of the ingredients of the formulation used, or any of the medications used
* Any other restriction according to the use of ranibizumab
* Active intraocular inflammation (grade trace or above) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Colorado Springs, Colorado, United States
Baltimore, Maryland, United States
Dallas, Texas, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Belfast, , United Kingdom
Bristol, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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2013-001972-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP28936
Identifier Type: -
Identifier Source: org_study_id