Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Steven Schwartz (ucla)

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

Official Title

A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease

Keywords

Stargardt's Macular Dystrophy, Zimura (previous name), ARC1905, complement factor C5 inhibitor, avacincaptad pegol, STGD1, Izervay, Stargardt Disease 1, Stargardt Disease, Macular Degeneration

Eligibility

You can join if…

Open to people ages 18-60

  • At least two pathogenic mutations of ATP-Binding Cassette (ABC)A4 gene confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
  • Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive

You CAN'T join if...

  • Macular atrophy secondary to any condition other than STGD1 in either eye
  • Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye
  • Participation in an interventional study of a vitamin A derivative </= 3 months prior to screening
  • Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia
  • Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region
  • Diabetes mellitus
  • Hemoglobin A1c (HbA1c) value of >/=6.5%
  • Stroke within 12 months of trial entry
  • Any major surgical procedure within one month of trial entry or anticipated during the trial
  • Any treatment with an investigational agent in the past 60 days for any condition
  • Women who are pregnant or nursing
  • Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation

Locations

  • Jules Stein Eye Institute/ David Geffen School of Medicine
    Los Angeles California 90095 United States
  • Retinal Research Institute
    Phoenix Arizona 85053 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT03364153
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 121 people participating
Last Updated