Safety and Efficacy of IONIS-FB-Lrx in up to 120 Patients 55 and Older With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

• Status: Withdrawn
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Complement Factor B; Complement System Proteins

Criteria

Key Inclusion Criteria:

1. Must have given written informed consent and be able to comply with study requirements

2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo)

3. Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration

Key Exclusion Criteria:

1. Clinically-significant abnormalities in medical history

2. Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease

3. Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months

4. Clinically-significant abnormalities in screening laboratory values

5. Unwillingness to be administered, or history of a serious reaction to protocol required vaccines

6. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B

7. History or presence of a disease other than AMD in study eye