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

Not Recruiting

Trial ID: NCT04435366

Purpose

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants 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

Stanford Investigator(s)

Diana Do, MD
Diana Do, MD

Professor of Ophthalmology

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

Intervention(s):

drug: Sham

drug: Avacincaptad Pegol

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305