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

Sponsor
IVERIC bio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03364153
Collaborator
(none)
120
Enrollment
42
Locations
2
Arms
63.6
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 12, 2018
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Spectral Domain-Optical Coherence Tomography (SD-OCT) [18 months]

      Mean rate of change in the area of ellipsoid zone defect measured by en face SD-OCT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Phoenix Arizona United States 85053
    2 Jules Stein Eye Institute/ David Geffen School of Medicine Los Angeles California United States 90095
    3 VitreoRetinal Associates Gainesville Florida United States 32607
    4 Retinal Specialty Institute Pensacola Florida United States 32503
    5 Wilmer Eye Institute, Johns Hopkins Baltimore Maryland United States 21287
    6 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
    7 Kellogg Eye Center Ann Arbor Michigan United States 48105
    8 Retina Center P.A. Minneapolis Minnesota United States 55404
    9 Retina Center of New Jersey, LLC Bloomfield New Jersey United States 07003
    10 Oregon Health & Science University Portland Oregon United States 97239
    11 Mid Atlantic Retina Philadelphia Pennsylvania United States 19107
    12 UPMC Eye Center Pittsburgh Pennsylvania United States 15213
    13 Palmetto Retina Center West Columbia South Carolina United States 29169
    14 Austin Retina Associates Austin Texas United States 78705
    15 Retina Foundation of the Southwest Dallas Texas United States 75231
    16 Strategic Clinical Research Group Willow Park Texas United States 76087
    17 University of Utah John A. Moran Eye Center Salt Lake City Utah United States 84132
    18 Montreal Children's Hospital Montréal Canada H4A 3J1
    19 Hopital de la Croix-Rousse Lyon Rhone-Alpes France 69317
    20 Hopital Intercommunal de Verdun, University Paris Est Créteil France 94000
    21 Centre ophtalmologique des Quinzes Vingts Paris France 75012
    22 University of Bonn Bonn Germany 53127
    23 Augenklinik und Poliklinik des Klinikums der Universitat München München Germany 80336
    24 Universitätsklinikum Tübingen Tübingen Germany 72076
    25 Budapest Retina Associates Budapest Hungary 1133
    26 Semmelweis University, Ophthalmology Clinics Budapest Hungary H-1085
    27 Debreceni Egyetem Klinikai Kozpont Szemklinika Debrecen Hungary 4032
    28 Ganglion Medical Center Pécs Hungary 7621
    29 Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika Szeged Hungary 6720
    30 Rambam Health Care Campus Haifa Israel 310960
    31 Hadassah Medical Center Jerusalem Israel 91120
    32 Rabin Medical Center, Beilinson campus Petah tikva Israel 4941492
    33 Kaplan Medical Center Reẖovot Israel 7610001
    34 Tel-Aviv Sourasky Medical Center, Ichilov Hospital Tel Aviv Israel 64239
    35 AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia, Bologna Italy 40138
    36 AOU Careggi Florence Italy 50134
    37 IRCCS Ospedale San Raffaele Milano Italy 20132
    38 AOU Universita degli studi della Campania Luigi Vanvitelli - UOC Oculistica Naples Italy 80131
    39 Foundation Policlinico Tor Vergata, UOSD Patologie Retiniche Rome Italy 00133
    40 Institut de la Macula Barcelona Spain 08022
    41 Princess Alexandra Eye Pavillion Edinburgh United Kingdom EH3 9HA
    42 Moorfields Eye Hospital London United Kingdom EC1V 2PD

    Sponsors and Collaborators

    • IVERIC bio, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IVERIC bio, Inc.
    ClinicalTrials.gov Identifier:
    NCT03364153
    Other Study ID Numbers:
    • OPH2005
    First Posted:
    Dec 6, 2017
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IVERIC bio, Inc.
    Zimura
    ARC1905
    complement factor C5 inhibitor
    avacincaptad pegol
    STGD1
    Additional relevant MeSH terms:
    Stargardt Disease
    Macular Degeneration

    Study Results

    No Results Posted as of Sep 24, 2021