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Trial record 1 of 1 for:    Phase 2b Stargardt
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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 9, 2022
Sponsor:
Information provided by (Responsible Party):
IVERIC bio, Inc.

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date September 9, 2022
Actual Study Start Date  ICMJE January 12, 2018
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stargardt Disease 1
Intervention  ICMJE
  • Drug: Zimura
    Zimura Intravitreal Injection
    Other Name: avacincaptad pegol
  • Other: Sham
    Sham Intravitreal Injection
Study Arms  ICMJE
  • Experimental: Cohort 1
    Zimura dose group
    Intervention: Drug: Zimura
  • Sham Comparator: Cohort 2
    Sham dose group
    Intervention: Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sonia Cruz 347-322-8722 sonia.cruz@ivericbio.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03364153
Other Study ID Numbers  ICMJE OPH2005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party IVERIC bio, Inc.
Original Responsible Party Ophthotech Corporation
Current Study Sponsor  ICMJE IVERIC bio, Inc.
Original Study Sponsor  ICMJE Ophthotech Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IVERIC bio, Inc.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP