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Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02686658
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : May 11, 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 were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Geographic Atrophy Macular Degeneration Drug: Zimura Other: Sham Phase 2 Phase 3

Detailed Description:
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The Reading Center team and Sponsor were also masked.
Primary Purpose: Treatment
Official Title: A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Actual Study Start Date : January 20, 2016
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zimura 1 mg [Part 1]
Participants received 1 mg of Zimura in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
 Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol
Experimental: Zimura 2 mg [Part 1]
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
 Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol
Sham Comparator: Sham [Part 1]
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
 Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Experimental: Zimura 2 mg (Zimura 2mg+Sham) [Part 2]
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
 Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol

Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Experimental: Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]
Participants received 4 mg of Zimura in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
 Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol
Sham Comparator: Sham (Sham+Sham) [Part 2]
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
 Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed 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. Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence [ Time Frame: Baseline and 12 months ]
    The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.


Secondary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters [ Time Frame: Baseline and 12 months ]
    The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

  2. Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters [ Time Frame: Baseline and 12 months ]
    The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.


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:

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

Exclusion Criteria:

  • Evidence of Choroidal Neovascularization (CNV)
  • GA secondary to any condition other than AMD
  • Any prior treatment for AMD 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 three (3) months of trial entry
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection in the twelve (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): NCT02686658


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] March 28, 2018
Statistical Analysis Plan  [PDF] July 19, 2019

More Information
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Publications of Results:

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Responsible Party: IVERIC bio, Inc.
ClinicalTrials.gov Identifier: NCT02686658    
Other Study ID Numbers: OPH2003
2015-003991-56 ( EudraCT Number )
First Posted: February 19, 2016    Key Record Dates
Results First Posted: May 11, 2023
Last Update Posted: February 23, 2024
Last Verified: April 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)
Dry age-related macular degeneration
AMD
Zimura
 Anti-inflammatory
complement factor C5 inhibitor
ARC1905
avacincaptad pegol
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical