Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy

Pfizer

Status and phase

Completed

Phase 1

Conditions

Macular Degeneration

Retinal Degeneration

Age-Related Maculopathy

Age-Related Maculopathies

Eye Diseases

Treatments

Biological: RN6G

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01003691

B1181002

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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 nervous immune, or gastrointestinal system
Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve