Overview
The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)
Description
Patients will be randomized in a 1:1 ratio to the following monthly treatment groups:
- Zimura 2 mg
- Sham
At month 12, the patients in the Zimura 2mg treatment group will be re-randomized to receive the study drug either on a monthly basis or on an every other month basis
The patients initially randomized to Sham treatment will continue with monthly Sham injections through Month 23
All patients will have a final follow up visit at Month 24
Eligibility
Inclusion Criteria:
- Subjects of either gender aged 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria:
- Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
- Any intraocular surgery or thermal laser within 3 months of trial entry.
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
- Previous therapeutic radiation in the region of the study eye
- Any sign of diabetic retinopathy in either eye