Status:
COMPLETED
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Lead Sponsor:
Pfizer
Conditions:
Age-Related Maculopathy
Age-Related Maculopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
Eligibility Criteria
Inclusion
- Be of non-childbearing potential.
- Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
- BCVA of 20/320 or better in the worst eye.
Exclusion
- Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
- Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
- Diagnosis or recent history of clinically significant cerebrovascular disease.
- Uncontrolled hypertension.
- Uncontrolled Type 1 or Type 2 diabetes mellitus.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00877032
Start Date
April 1 2009
End Date
July 1 2011
Last Update
March 31 2015
Active Locations (20)
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1
Dedicated Phase 1
Phoenix, Arizona, United States, 85013
2
Retinal Consultants of AZ
Phoenix, Arizona, United States, 85014
3
Insight Diagnostic Imaging Center
Phoenix, Arizona, United States, 85015
4
Amir Hedayati-Rad, MD
Glendale, California, United States, 91206