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

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

NCT00877032

B1181001

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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57 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Biological: Placebo

Biological: RN6G