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

a study on Geographic Atrophy Macular Degeneration

Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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)

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

Details

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

Keywords

Geographic Atrophy Macular Degeneration Geographic Atrophy (GA) Age-related Macular Degeneration AMD Zimura Complement C5 inhibitor avacincaptad pegol Atrophy

Eligibility

You can join if…

Open to people ages 50 years and up

  • Subjects of either gender aged ≥ 50 years
  • Diagnosis of Non-foveal GA secondary to dry AMD

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Orange County Retinal Medical Group accepting new patients
    Santa Ana California 92705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
IVERIC bio, Inc.
ID
NCT04435366
Phase
Phase 3
Study Type
Interventional
Last Updated
Contact us about this trial