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A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

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ClinicalTrials.gov Identifier: NCT04435366
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
IVERIC bio, Inc.

Study Description
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Brief Summary:
The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

Condition or disease Intervention/treatment Phase
Geographic Atrophy Macular Degeneration Drug: Zimura Drug: Sham Phase 3

Detailed Description:

Patients will be randomized in a 1:1 ratio to the following monthly treatment groups:

  • Zimura 2 mg
  • Sham

At month 12, the patients in the Zimura 2mg treatment group will be re-randomized to receive the study drug either on a monthly basis or on an every other month basis

The patients initially randomized to Sham treatment will continue with monthly Sham injections through Month 23

All patients will have a final follow up visit at Month 24

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are masked
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zimura Treatment Group
Monthly Zimura 2mg Intravitreal Injections, followed by monthly injections or every other month injections from Month 12 to Month 23
 Drug: Zimura
Zimura Intravitreal Injection
Other Name: avacincaptad pegol
Sham Comparator: Sham Treatment Group
Monthly Sham Administration until Month 23
 Drug: Sham
Sham Injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean rate of change in GA over 12 months (measured at three time points: Baseline, Month 6, and Month 12) [ Time Frame: Baseline, Month 6, Month 12 ]
    Mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at three time points: Baseline, Month 6, and Month 12


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years
  • Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

  • Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
  • Any intraocular surgery or thermal laser within 3 months of trial entry.
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
  • Previous therapeutic radiation in the region of the study eye
  • Any sign of diabetic retinopathy in either eye
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): NCT04435366


Contacts
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Contact: Natasha Arora 212-845-8245 natasha.malik@ivericbio.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: NCT04435366    
Other Study ID Numbers: ISEE2008
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: August 2020

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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.:
Geographic Atrophy (GA)
Age-related Macular Degeneration
AMD
 Zimura
Complement C5 inhibitor
avacincaptad pegol
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical