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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 : Completed
First Posted : June 17, 2020
Results First Posted : December 28, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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 (avacincaptad pegol) 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: Avacincaptad Pegol Drug: Sham Phase 3

Detailed Description:

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

  • Avacincaptad pegol 2 mg
  • Sham

At Month 12, the participants in the avacincaptad pegol 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 participants initially randomized to sham treatment will continue with monthly sham administration through Month 23

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 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 22, 2020
Actual Primary Completion Date : July 25, 2022
Actual Study Completion Date : August 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Avacincaptad Pegol Treatment Group
Monthly avacincaptad pegol 2mg intravitreal injections through Month 11 (Year 1) NOTE: At Month 12, participants are re-randomized to receive monthly injections or every other month injections (alternating with sham) from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.
 Drug: Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Other Names:
  • Zimura
  • IZERVAY
Sham Comparator: Sham Treatment Group
Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.
 Drug: Sham
Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an 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 and Month 12 ]
    The least squares mean rate of growth (slope) estimated based on geographic atrophy (GA) area measured by fundus autofluorescence (FAF) in at least 3 timepoints: Baseline, Month 6, and Month 12 was used to determine mean rate of change (slope) in GA from Baseline to Month 12. The square root of the GA area was used in the analysis.


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


Locations
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Sponsors and Collaborators
IVERIC bio, Inc.
  Study Documents (Full-Text)

Documents provided by Astellas Pharma Inc ( IVERIC bio, Inc. ):
Study Protocol  [PDF] May 24, 2021
Statistical Analysis Plan  [PDF] April 7, 2022

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
Results First Posted: December 28, 2023
Last Update Posted: February 23, 2024
Last Verified: November 2023

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