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

Sponsor
IVERIC bio, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02686658
Collaborator
(none)
286
Enrollment
78
Locations
6
Arms
51.7
Actual Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jan 1, 2016
Actual Primary Completion Date :
Sep 26, 2019
Actual Study Completion Date :
Apr 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Group 1

Zimura Dose Administration 1

Drug: Zimura
Zimura Dose Administration 1
Other Names:
  • avacincaptad pegol

    		•
    Experimental: Dose Group 2

    Zimura Dose Administration 2

    Drug: Zimura
    Zimura Dose Administration 2
    Other Names:
  • 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 Names:
  • avacincaptad pegol

    		•
    Experimental: Dose Group 5

    Zimura Dose Administration 4

    Drug: Zimura
    Zimura Dose Administration 4
    Other Names:
  • avacincaptad pegol

    		•
    Sham Comparator: Dose Group 6

    Sham Administration 2

    Other: Sham
    Sham Administration 2

    Outcome Measures

    Primary Outcome Measures

    1. Change in geographic atrophy (GA) [12 months]

      Mean rate of change in GA measured by fundus autofluorescence (FAF)

    Secondary Outcome Measures

    1. Best Corrected Visual Acuity (BCVA) [12 months]

      Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States 85053
    2 Tucson Arizona United States 85704
    3 Tucson Arizona United States 85710
    4 Campbell California United States 95008
    5 Fresno California United States 93720
    6 Fullerton California United States 92835
    7 La Jolla California United States 92093
    8 Mountain View California United States 94040
    9 Redlands California United States 92374
    10 Sacramento California United States 95819
    11 Sacramento California United States 95841
    12 Santa Ana California United States 92705
    13 Denver Colorado United States 80210
    14 Altamonte Springs Florida United States 32701
    15 Boynton Beach Florida United States 33426
    16 Melbourne Florida United States 32901
    17 Saint Petersburg Florida United States 33711
    18 Stuart Florida United States 34994
    19 Winter Haven Florida United States 33880
    20 Augusta Georgia United States 30909
    21 Marietta Georgia United States 30060
    22 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701
    23 West Des Moines Iowa United States 50266
    24 Shawnee Mission Kansas United States 66204
    25 Wichita Kansas United States 67214
    26 Baltimore Maryland United States 21209
    27 Chevy Chase Maryland United States 20815
    28 Boston Massachusetts United States 02114
    29 Springfield Massachusetts United States 01107
    30 Grand Rapids Michigan United States 49546
    31 Henderson Nevada United States 89052
    32 Reno Nevada United States 89502
    33 Rochester New York United States 14620
    34 Syracuse New York United States 13224
    35 Asheville North Carolina United States 28803
    36 Charlotte North Carolina United States 28210
    37 Hickory North Carolina United States 28602
    38 Cincinnati Ohio United States 45242
    39 Cleveland Ohio United States 44130
    40 Cleveland Ohio United States 44136
    41 Portland Oregon United States 97221
    42 Philadelphia Pennsylvania United States 19107
    43 West Mifflin Pennsylvania United States 15122
    44 Ladson South Carolina United States 29456
    45 West Columbia South Carolina United States 29169
    46 Abilene Texas United States 79606
    47 Amarillo Texas United States 79106
    48 Austin Texas United States 78705
    49 Grapevine Texas United States 76051
    50 Houston Texas United States 77030
    51 The Woodlands Texas United States 77384
    52 Willow Park Texas United States 76087
    53 Salt Lake City Utah United States 84107
    54 Salt Lake City Utah United States 84132
    55 Richmond Virginia United States 23235
    56 Clinical hospital center Osijek Osijek Croatia 31000
    57 Fakultni Nemocnice Brno Brno Czechia 62500
    58 Faculty Hospital Hradec Kralove Hradec Králové Czechia 50005
    59 Fakultni nemocnice Olomouc Olomouc Czechia 77900
    60 Axon Clinical SRO Praha Czechia 15000
    61 East Tallinn Central Hospital Tallinn Estonia 10138
    62 Dr.Kai Noor Eye Clinic Tallinn Estonia 11412
    63 Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet Budapest Hungary 1076
    64 Budapest Hungary 1083
    65 Budapest Hungary 1106
    66 Budapest Hungary 1133
    67 Budapest Hungary 1145
    68 Debrecen Hungary 4012
    69 Pecs Hungary 7621
    70 Szeged Hungary 6720
    71 Veszprém Hungary 8200
    72 Rambam Medical Center Haifa Israel 3109601
    73 Hadassah University Hospital Jerusalem Israel 91120
    74 Meir Medical Center Kfar Saba Israel 4428164
    75 Rabin Medical Center Petah tikva Israel 4941492
    76 Kaplan Medical Center Reẖovot Israel 76100
    77 Tel-Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    78 Pauls Stradins Clinical University Hospital Riga Latvia LV1002

    Sponsors and Collaborators

    • IVERIC bio, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IVERIC bio, Inc.
    ClinicalTrials.gov Identifier:
    NCT02686658
    Other Study ID Numbers:
    • OPH2003
    First Posted:
    Feb 19, 2016
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    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:
    Macular Degeneration
    Geographic Atrophy
    Atrophy

    Study Results

    No Results Posted as of Mar 21, 2022