Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT01577381
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- Men and women between the ages of 60 and 90 years.
- Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration.
- Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye
- Evidence of ocular disease other than geographic atrophy (GA) secondary to dry
Age-Related Macular Degeneration in the study eye.
- History or diagnosis of exudative (wet) Age-Related Macular Degeneration, 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
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration | |||
Official Title ICMJE | A Phase 2 Multi-center, Randomized, Double-masked, Placebo-controlled, Multi-dose Study To Investigate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of Rn6g (Pf-04382923) In Subjects With Geographic Atrophy Secondary To Age-related Macular Degeneration | |||
Brief Summary | The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration. | |||
Detailed Description | The trial was terminated early on April 12, 2013 due to an organizational decision, which was not based on safety or efficacy concerns. Subjects who were already enrolled into the study were followed. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Age-Related Maculopathy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 10 | |||
Original Estimated Enrollment ICMJE | 276 | |||
Actual Study Completion Date ICMJE | October 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Germany, United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01577381 | |||
Other Study ID Numbers ICMJE | B1181003 2012-000823-42 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |