A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Trial ID or NCT#

NCT04435366

Status

not recruiting iconNOT RECRUITING

Purpose

The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad pegol) intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

Official Title

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligibility Criteria

Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Subjects of either gender aged ≥ 50 years* Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria:
  1. * 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

Investigator(s)

Diana Do, MD
Diana Do, MD
Retina specialist, Ophthalmologist
Professor of Ophthalmology