Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects 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 Disease 1 Zimura ARC1905 complement factor C5 inhibitor avacincaptad pegol STGD1 Macular Degeneration

Eligibility

You can join if…

Open to people ages 18-50

  • At least two pathogenic mutations of ABCA4 gene confirmed by a 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
  • 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 Zimura formulation

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
IVERIC bio, Inc.
ID
NCT03364153
Phase
Phase 2
Study Type
Interventional
Last Updated