Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
NCT ID: NCT01003691
Last Updated: 2022-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-08-05
2013-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
RN6G
Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
Placebo
Intravenous, multiple dose with experimental dose
Interventions
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RN6G
Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
Placebo
Intravenous, multiple dose with experimental dose
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement
* BCVA of 20/50 or better in the study eye
Exclusion Criteria
* History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye
* Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system
* Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve
60 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Retinal Diagnostic Center
Campbell, California, United States
American Institute of Research (Administrative Only)
Los Gatos, California, United States
Neurology Center Rai Kumar
San Jose, California, United States
Harmeet Sachdev, MD, FAAN
San Jose, California, United States
Santa Clara Drug
San Jose, California, United States
Retina Associates of Florida, PA
Tampa, Florida, United States
Hoye's Pharmacy
Tampa, Florida, United States
Ranjit K. Sethi, MD, PC
Augusta, Georgia, United States
Clinical Specialists, LLC
Augusta, Georgia, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Hawthorne Pharmacy
West Columbia, South Carolina, United States
Jay Markowitz and Associates
West Columbia, South Carolina, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States
South Carolina Neurological
West Columbia, South Carolina, United States
National Central Pharmacy
Abilene, Texas, United States
Abilene Surgery Center
Abilene, Texas, United States
Heart and Vascular Institute
Abilene, Texas, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Brian B. Berger, MD, PA
Austin, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Sleep Medicine Consultants
Austin, Texas, United States
Specialty Compounding
Cedar Park, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1181002
Identifier Type: -
Identifier Source: org_study_id
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