Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2010 |
| End Date: | February 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Double-Masked, Placebo-Controlled Study Evaluating The Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Dosages Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration (AMD) Including Geographic Atrophy
The purpose of this study is to determine the safety and tolerability of multiple doses of
RN6G in subjects with advanced dry, age-related macular degeneration including geographic
atrophy.
Inclusion Criteria:
- Be of non-child bearing potential
- 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:
- Evidence of ocular disease other than advanced AMD or GA in the study eye
- 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 nervousm immune, or
gastrointestinal system
- Requires ocular or systemic medications that are known to be toxic to the lens,
retina or optic nerve
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