Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

Completed · Phase 1 · Has a placebo group

Conditions studied: Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration

In brief

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

Key facts

Study ID

NCT00877032

Run by

Pfizer

People needed

57

Starts

2009-04-01

Expected to finish

2011-07-01

Last updated by the study team

2015-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dedicated Phase 1 — Phoenix, Arizona, United States
• Retinal Consultants of AZ — Phoenix, Arizona, United States
• Insight Diagnostic Imaging Center — Phoenix, Arizona, United States
• Amir Hedayati-Rad, MD — Glendale, California, United States
• United Medical Imaging — Inglewood, California, United States
• United Medical Research Institute — Inglewood, California, United States
• California Pharmacy and Compounding Center — Newport Beach, California, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Jonathan Rowe, MD — Kalamazoo, Michigan, United States
• Ronald VanderLugt, MD — Kalamazoo, Michigan, United States
• CEDRA Clinical Research, LLC — San Antonio, Texas, United States
• Village Drive Imaging Center — San Antonio, Texas, United States
• Specialty MRI — San Antonio, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retinal Consultants of San Antonio — San Antonio, Texas, United States
• EZ Pass Rx — Bountiful, Utah, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States
• Rocky Mountain Eye Care Associates, LC — Salt Lake City, Utah, United States
• Western Neurological Associates — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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