Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

February 20, 2024 updated by: IVERIC bio, Inc.

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

To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France, 94010
        • Creteil University Eye Clinic University Paris EST
      • Paris, France, 75012
        • Centre ophtalmologique des Quinzes Vingts
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69004
        • Hôpital de la Croix-Rousse
  • Germany
      • Bonn, Germany, 53127
        • University of Bonn
      • München, Germany, 80336
        • Augenklinik der LMU München
      • Tübingen, Germany, 72076
        • University of Tuebingen
  • Hungary
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1133
        • Budapest Retina Institute
      • Debrecen, Hungary, 4032
        • University of Debrecen DE KK Szemészeti Klinika
      • Pécs, Hungary, 7621
        • Ganglion Medical Center
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital
      • Petah tikva, Israel, 4941492
        • Rabin Medical Center, Beilinson Campus
      • Reẖovot, Israel, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center, Ichilov Hospital
  • Italy
      • Bologna, Italy, 40138
        • AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,
      • Florence, Italy, 50121
        • Azienda Ospedaliera Universitaria Careggi
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Naples, Italy, 80131
        • University of Campania Luigi Vanvitelli Eye Clinic
      • Rome, Italy, 00133
        • Fondazione Policlinico Tor Vergata, UOSD Patologie Retiniche
  • Spain
      • Barcelona, Spain, 08022
        • Institut de la Macula
  • United Kingdom
      • Edinburgh, United Kingdom, EH3 9HA
        • Princess Alexandra Eye Pavillion
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute
    • California
      • Los Angeles, California, United States, 90095
        • Jules Stein Eye Institute/ David Geffen School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32607
        • VitreoRetinal Associates
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute, Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan/Kellogg Eye Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • The Retina Center
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute/Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital/Mid Atlantic Retina
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye Center
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah John A. Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Zimura dose group
Drug: Zimura
Zimura Intravitreal Injection
Other Names:
  • avacincaptad pegol
Sham Comparator: Cohort 2
Sham dose group
Other: Sham
Sham Intravitreal Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time Frame: 18 months
Mean rate of change in the area of ellipsoid zone defect measured by en face SD-OCT
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVERIC bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2018

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH2005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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