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

Primary Purpose

Geographic Atrophy, Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avacincaptad Pegol
Sham
Sponsored by
IVERIC bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Zimura, Complement C5 inhibitor, avacincaptad pegol, IZERVAY

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Retinal Diagnostic Center
  • Eye Medical Center of Fresno
  • Retina Consultants of Orange County
  • University of California, San Diego
  • Jules Stein Eye Institute/David Geffen School of Medicine
  • Northern California Retina Vitreous Associates
  • California Retina Consultants
  • Southern California Desert Retina Consultants
  • Doheny Eye Center, UCLA
  • Retina Consultants of Southern California
  • Retinal Consultants Medical Group, Inc.
  • Orange County Retinal Medical Group
  • University of Colorado
  • Retina Consultants of Southern Colorado, P.C.
  • Colorado Retina Associates
  • Connecticut Eye Consultants, P.C.
  • Retina Group of New England, PC
  • Florida Eye Clinic
  • Rand Eye Institute
  • Retina Group of Florida
  • Retina Health Center
  • National Ophthalmic Research Institute
  • VitreoRetinal Associates, P.A.
  • Florida Eye Associates
  • University of Miami-Bascom Palmer Eye Institute
  • Retina Care Specialists
  • Retina Specialty Institute
  • Retina Vitreous Associates of Florida
  • Retina Associates of Sarasota
  • East Florida Eye Institute
  • Southern Vitreoretinal Associates, PL
  • Center for Retina and Macula Disease
  • Southeast Retina Center
  • Georgia Retina, P.C.
  • Retina Consultants of Hawaii, Inc
  • University Retina and Macula Associates, PC
  • Illinois Eye Center
  • Midwest Eye Institute
  • Wolfe Eye Clinic
  • Retina Associates, LLC
  • Vitreo Retinal Consultants & Surgeons
  • Ochsner Medical Center
  • The Retina Care Center
  • The Retina Group of Washington
  • Cumberland Valley Retina Consultants
  • Ophthalmic Consultants of Boston
  • Retina Research Institute at New England Retinal Consultants
  • UMASS Memorial Eye Center
  • Vitreoretinal Associates, PC
  • Associated Retinal Consultants, P.C.
  • Retina Center
  • St. Louis University
  • Retina Consultants of Nevada
  • Sierra Eye Associates
  • Retina Center of New Jersey, LLC
  • Long Island Vitreoretinal Consultant
  • Retina Vitreous Surgeons of Central New York, PC
  • Vitreous Retina Macula Consultants of New York (VRMNY)
  • OCLI
  • Retina Associates of Western NY, PC
  • Ophthalmic Consultants of the Capital Region
  • Western Carolina Retinal Associates
  • Cincinnati Eye Institute
  • Retina and Vitreous Center of Southern Oregon
  • Retina Northwest, PC
  • EyeHealth Northwest
  • Casey Eye Institute
  • Scheie Eye Institute, University of Pennsylvania
  • Mid Atlantic Retina
  • Associates in Ophthalmology, Ltd
  • Retina Research of Beaufort, LLC
  • Charleston Neuroscience Institute
  • Carolina Macula and Retina
  • Palmetto Retina Center
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates, PC
  • Southeastern Retina Associates, PC
  • Retina Research Institute of Texas
  • Southwest Retina Specialists
  • Austin Retina Associates
  • Retina Foundation of the Southwest
  • Retina and Vitreous of Texas, PLLC
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retina Center of Texas
  • Retinal Consultants of Houston
  • Strategic Clinical Research Group
  • Retinal Associates of Utah
  • Rocky Mountain Retina Consultants
  • University of Utah, John A. Moran Eye Center
  • Wagner Macular & Retina Center
  • Retina Institute of Virginia
  • Vistar Eye Center
  • Pacific Northwest Retina
  • Retina Center NW, PLLC
  • Centro Oftalmológico Dr. Charles SA
  • Buenos Aires Macula S.A.
  • Centro Médico Grupo Laser Visión
  • Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
  • Instituto Oftalmológico de Buenos Aires
  • Centro Privado de Ojos Romagosa S.A.
  • Instituto Oftalmológico de Córdoba
  • Centro Privado de Oftalmologia - OFTAR Mendoza SRL
  • Centro Medico Micro Diagnostico y Microcirugla Ocular
  • Sydney Eye Hospital
  • Sydney Retina Clinic and Day Surgery
  • Royal Victorian Eye & Ear Hospital
  • Medizinische Universitaet Graz - Augenklinik
  • Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
  • Medical University of Vienna
  • Hanush Hospital
  • CHU Brugmann
  • Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
  • IPEPO - Instituto da visão
  • Hospital Sao Paulo - UNIFESP
  • Calgary Retina Consultants
  • UBC/VGH Eye Care Center
  • St.Joseph's Health Care London
  • Canadian Centre for Advanced Eye Therapeutics Inc.
  • University of Ottawa Eye Institute
  • University Health Network
  • Retina Centre of Ottawa
  • Clinica De Oftalmologia Sandiego
  • Fundacion OJlalmologica Nacional - FUNDONAL
  • Clinical hospital Center Osijek
  • Axon Clinical s.r.o.
  • Dr Kai Noor Silmakabinet
  • Tartu University Hospital
  • CHU de Bordeaux - Hopital Pellegrin
  • Hopital Intercommunal
  • CHU Bocage
  • Centre d'ophtalmologie Rabelais
  • Hopital de la Croix Rousse
  • Centre Paradis Monticelli
  • CHU de Nantes
  • Centre d'exploration ophtalmologique de l'Odeon
  • Hôpital Lariboisière
  • Centre Ophtalmologique d'Imagerie et de Laser
  • Fondation Alolphe de Rotschild
  • Centre St Exupery
  • Centre Pole Vision Val d'Ouest
  • RWTH Aachen University
  • University of Bonn
  • University of Göttingen
  • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
  • University Eye Hospital, MHH
  • Augenklinik University Hospital Cologne
  • University clinic Leipzig AÖR
  • Universitätsklinikum Schleswig-Holstein
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Ludwig-Maximilians-University Munich
  • Clinic Rechts der Isar
  • Augenzentrum am St. Franziskus-Hospital
  • Universitätsklinikum Münster
  • Universitäts-Augenklinik
  • Hungarian Military Hospital Center
  • Bajcsy Zsilinszky Kórház - Szemészet
  • Budapest Retina Associates
  • Semmelweis University, Dept of Ophthalmology
  • Debrecen University Clinical Center, Dept of Ophthalmology
  • Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
  • Ganglion Medical Center
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Barzilai Medical Center
  • Shamir Medical Center
  • Rambam Medical Centre
  • Carmel Medical Center
  • Edith Wolfson Medical Center
  • Hadassah University Hospital
  • Department of Ophthalmology, Rabin Medical Center
  • Kaplan Medical Center
  • Sourasky Medical Center
  • Ospedali Riuniti di Ancona
  • A.O.U. Policlinico Sant'Orsola-Malpighi
  • Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
  • Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
  • Azienda Ospedaliera Universitaria Careggi
  • Ospedale Maggiore Policlinico Milano
  • IRCCS Ospedale San Raffaele
  • Ospedale Luigi Sacco
  • AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
  • Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
  • University of Pisa
  • Fondazione PTV
  • Fondazione GB Bietti IRCCS
  • Azienda Sanitaria Universitaria Integrata
  • Pauls Stradinis Clinical University Hospital
  • Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
  • Caminomed
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Medical Center Julianów
  • Clinica de Oftalmologia Barraquer
  • Institut Catala de Retina
  • Institut de la Macula
  • VOR - Hospital General de Catalunya
  • Instituto Clinico Quirurgico de Oftalmologia
  • Hospital La Arruzafa
  • H.U. Puerta de Hierro-Majadahonda
  • Clinica Universidad de Navarra
  • Instituto Oftalmologico Gomez-Ulla
  • IMED Servicio Oftalmología
  • Rio Hortega University Hospital
  • Hospital Clínico Universitario "Lozano Blesa"
  • Hull University Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Avacincaptad Pegol Treatment Group

Sham Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean rate of change in GA over 12 months (measured at three time points: Baseline, Month 6, and 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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2020
Last Updated
October 5, 2023
Sponsor
IVERIC bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04435366
Brief Title
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
August 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVERIC bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Macular Degeneration
Keywords
Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Zimura, Complement C5 inhibitor, avacincaptad pegol, IZERVAY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are masked
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avacincaptad Pegol Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Treatment Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Avacincaptad Pegol
Other Intervention Name(s)
Zimura, IZERVAY
Intervention Description
Avacincaptad Pegol Intravitreal Injection
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
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)
Primary Outcome Measure Information:
Title
Mean rate of change in GA over 12 months (measured at three time points: Baseline, Month 6, and Month 12)
Description
Mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at three time points: Baseline, Month 6, and Month 12
Time Frame
Baseline, Month 6, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Eye Medical Center of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Jules Stein Eye Institute/David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
California Retina Consultants
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
Doheny Eye Center, UCLA
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Retina Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Orange County Retinal Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Retina Consultants of Southern Colorado, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Connecticut Eye Consultants, P.C.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Retina Group of New England, PC
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
VitreoRetinal Associates, P.A.
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
University of Miami-Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Retina Care Specialists
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Retina Associates of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Southern Vitreoretinal Associates, PL
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Center for Retina and Macula Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Retina Consultants of Hawaii, Inc
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Retina Associates, LLC
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Vitreo Retinal Consultants & Surgeons
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
The Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Retina Research Institute at New England Retinal Consultants
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
UMASS Memorial Eye Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Vitreoretinal Associates, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Associated Retinal Consultants, P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Retina Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Retina Consultants of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Center of New Jersey, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Long Island Vitreoretinal Consultant
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Retina Vitreous Surgeons of Central New York, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Vitreous Retina Macula Consultants of New York (VRMNY)
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
OCLI
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Retina Associates of Western NY, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Ophthalmic Consultants of the Capital Region
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina and Vitreous Center of Southern Oregon
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
EyeHealth Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Scheie Eye Institute, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Associates in Ophthalmology, Ltd
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Retina Research of Beaufort, LLC
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Carolina Macula and Retina
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Southwest Retina Specialists
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina and Vitreous of Texas, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Center of Texas
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Retinal Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Retinal Associates of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Rocky Mountain Retina Consultants
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah, John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Wagner Macular & Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Vistar Eye Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Pacific Northwest Retina
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Retina Center NW, PLLC
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Centro Oftalmológico Dr. Charles SA
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1116ABA
Country
Argentina
Facility Name
Buenos Aires Macula S.A.
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
Cl061AAE
Country
Argentina
Facility Name
Centro Médico Grupo Laser Visión
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
CP2000
Country
Argentina
Facility Name
Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000ANJ
Country
Argentina
Facility Name
Instituto Oftalmológico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Centro Privado de Ojos Romagosa S.A.
City
Córdoba
ZIP/Postal Code
X5000AAJ
Country
Argentina
Facility Name
Instituto Oftalmológico de Córdoba
City
Córdoba
ZIP/Postal Code
X5000III
Country
Argentina
Facility Name
Centro Privado de Oftalmologia - OFTAR Mendoza SRL
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Facility Name
Centro Medico Micro Diagnostico y Microcirugla Ocular
City
Rosario
ZIP/Postal Code
S2000TC
Country
Argentina
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Sydney Retina Clinic and Day Surgery
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Royal Victorian Eye & Ear Hospital
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Medizinische Universitaet Graz - Augenklinik
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanush Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Brugmann
City
Brussels
Country
Belgium
Facility Name
Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
City
Belo Horizonte
ZIP/Postal Code
30330
Country
Brazil
Facility Name
IPEPO - Instituto da visão
City
São Paulo
ZIP/Postal Code
04038-032
Country
Brazil
Facility Name
Hospital Sao Paulo - UNIFESP
City
Vila Clementino
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Facility Name
UBC/VGH Eye Care Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z3N9
Country
Canada
Facility Name
St.Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4V2
Country
Canada
Facility Name
Canadian Centre for Advanced Eye Therapeutics Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Retina Centre of Ottawa
City
Ottawa
ZIP/Postal Code
K2B 7E9
Country
Canada
Facility Name
Clinica De Oftalmologia Sandiego
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050016
Country
Colombia
Facility Name
Fundacion OJlalmologica Nacional - FUNDONAL
City
Bogotá
ZIP/Postal Code
110311
Country
Colombia
Facility Name
Clinical hospital Center Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Axon Clinical s.r.o.
City
Prague
State/Province
Smichov
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Dr Kai Noor Silmakabinet
City
Tallin
ZIP/Postal Code
11412
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
CHU de Bordeaux - Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital Intercommunal
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre d'ophtalmologie Rabelais
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Paradis Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44043
Country
France
Facility Name
Centre d'exploration ophtalmologique de l'Odeon
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Ophtalmologique d'Imagerie et de Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Fondation Alolphe de Rotschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre St Exupery
City
Saint-Cyr-sur-Loire
ZIP/Postal Code
37540
Country
France
Facility Name
Centre Pole Vision Val d'Ouest
City
Écully
ZIP/Postal Code
69130
Country
France
Facility Name
RWTH Aachen University
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
University of Bonn
City
Bonn
Country
Germany
Facility Name
University of Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
University Eye Hospital, MHH
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Augenklinik University Hospital Cologne
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
University clinic Leipzig AÖR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Ludwig-Maximilians-University Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Clinic Rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Augenzentrum am St. Franziskus-Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitäts-Augenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hungarian Military Hospital Center
City
Budapest
ZIP/Postal Code
1068
Country
Hungary
Facility Name
Bajcsy Zsilinszky Kórház - Szemészet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Budapest Retina Associates
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Semmelweis University, Dept of Ophthalmology
City
Budapest
ZIP/Postal Code
H-1085
Country
Hungary
Facility Name
Debrecen University Clinical Center, Dept of Ophthalmology
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Ganglion Medical Center
City
Pécs
ZIP/Postal Code
H-7621
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Medical Centre
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Department of Ophthalmology, Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
A.O.U. Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale Maggiore Policlinico Milano
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fondazione PTV
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione GB Bietti IRCCS
City
Roma
ZIP/Postal Code
00198
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Pauls Stradinis Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Caminomed
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Medical Center Julianów
City
Łódź
ZIP/Postal Code
91-485
Country
Poland
Facility Name
Clinica de Oftalmologia Barraquer
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
Institut Catala de Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Institut de la Macula
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
VOR - Hospital General de Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Instituto Clinico Quirurgico de Oftalmologia
City
Bilbao
ZIP/Postal Code
48010
Country
Spain
Facility Name
Hospital La Arruzafa
City
Córdoba
ZIP/Postal Code
CP 14012
Country
Spain
Facility Name
H.U. Puerta de Hierro-Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Instituto Oftalmologico Gomez-Ulla
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
IMED Servicio Oftalmología
City
Valencia
ZIP/Postal Code
46100
Country
Spain
Facility Name
Rio Hortega University Hospital
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital Clínico Universitario "Lozano Blesa"
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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