Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:60 - 90
Updated:4/21/2016
Start Date:August 2012
End Date:October 2013

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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

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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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Brooklyn, New York 11238
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East Setauket, NY
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