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Zimura in Subjects 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
Last Update Posted : October 19, 2020
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 intravitreous administration of Zimura when administered in subjects 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:

Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose groups:

  • Zimura Dose Administration 1
  • Zimura Dose Administration 2
  • Sham Administration 1

Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose groups:

  • Zimura Dose Administration 3
  • Zimura Dose Administration 4
  • Sham Administration 2

Subjects 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 2016
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : April 23, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Group 1
Zimura Dose Administration 1
 Drug: Zimura
Zimura Dose Administration 1
Other Name: avacincaptad pegol
Experimental: Dose Group 2
Zimura Dose Administration 2
 Drug: Zimura
Zimura Dose Administration 2
Other Name: avaincaptad pegol
Sham Comparator: Dose Group 3
Sham Administration 1
 Other: Sham
Sham Administration 1
Experimental: Dose Group 4
Zimura Dose Administration 3
 Drug: Zimura
Zimura Dose Administration 3
Other Name: avacincaptad pegol
Experimental: Dose Group 5
Zimura Dose Administration 4
 Drug: Zimura
Zimura Dose Administration 4
Other Name: avacincaptad pegol
Sham Comparator: Dose Group 6
Sham Administration 2
 Other: Sham
Sham Administration 2


Outcome Measures
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Primary Outcome Measures :
  1. Change in geographic atrophy (GA) [ Time Frame: 12 months ]
    Mean rate of change in GA measured by fundus autofluorescence (FAF)


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]
    Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)


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:

  • 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.
More Information
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Responsible Party: IVERIC bio, Inc.
ClinicalTrials.gov Identifier: NCT02686658    
Other Study ID Numbers: OPH2003
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: October 19, 2020
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)
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