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

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ClinicalTrials.gov Identifier: NCT03364153
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
IVERIC bio, Inc.

Study Description
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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
Stargardt Disease 1 Drug: Zimura Other: Sham Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 12, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Zimura dose group
 Drug: Zimura
Zimura Intravitreal Injection
Other Name: avacincaptad pegol
Sham Comparator: Cohort 2
Sham dose group
 Other: Sham
Sham Intravitreal Injection


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364153


Contacts
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Contact: Sonia Cruz 347-322-8722 sonia.cruz@ophthotech.com

Locations
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Sponsors and Collaborators
IVERIC bio, Inc.
More Information
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Responsible Party: IVERIC bio, Inc.
ClinicalTrials.gov Identifier: NCT03364153    
Other Study ID Numbers: OPH2005
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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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:
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Stargardt Disease
Macular Degeneration
Eye Diseases, Hereditary
Eye Diseases
 Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn