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Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Primary Purpose

Geographic Atrophy, Macular Degeneration

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avacincaptad pegol 2 mg intravitreal injection
Sponsored by
IVERIC bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment.
  • Patient must provide new written informed consent for this OLE trial prior to participation.
  • Patient must have the ability to return for all trial visits for the duration of the 18-month trial.

Exclusion Criteria:

  • Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham),
  • Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.
  • Patient did not enroll into this OLE trial within the 90 day enrollment period.
  • Patient who is pregnant or nursing

Sites / Locations

  • Retinal Diagnostic Center
  • Eye Medical Center of Fresno
  • Retina Consultants of Orange County
  • Jacobs Retina Center at The Shiley Eye Institute USCD
  • Jules Stein Eye Institute David Geffen School of Medicine
  • Doheny Eye Center, UCLA
  • Retina Consultants of Southern California
  • Orange County Retinal Med Group
  • University of Colorado
  • Retina Consultants of Southern CO
  • Colorado Retina Associates, PC
  • Rand Eye Institute
  • Retina Group of Florida
  • Florida Eye Associates
  • Retina Care Specialists
  • Retina Vitreous Associates of Florida
  • Retina Associates of Sarasota
  • East Florida Eye Institute
  • Southern Vitreoretinal Associates
  • Center for Retina & Macula Disease
  • Southeast Retina Center P.C.
  • Retina Consultants of Hawaii, Inc.
  • Illinois Eye Center
  • Wolfe Eye Clinic
  • Vitreo Retinal Consultants & Surgeons
  • Ochsner Clinic Foundation
  • The Retina Group of Washington
  • Cumberland Valley Retina Consultants
  • Ophthalmic Consultants of Boston
  • Retina Research Institute at New England Retina
  • Vitreoretinal Associates PC
  • Sierra Eye Associates
  • Retina Vitreous Surgeons of Central New York
  • Ophthalmic Consultants of Long Island
  • Retina Associates of Western NY
  • Western Carolina Retinal Associates
  • Retina & Vitreous Center of Southern Oregon, PC
  • Retina Northwest PC
  • Eye Health Northwest
  • Mid Atlantic Retina - Wills Eye Institute
  • Associates in Ophthalmology
  • Retina Research of Beaufort
  • Palmetto Retina Center
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates, PC
  • Retina Research Institute of Texas, LLC
  • Southwest Retina Specialists
  • Austin Retina Associates
  • Retina Foundation of the Southwest
  • Retina Center of Texas
  • Retina Consultants of Houston
  • Strategic Clinical Research Group, LLC
  • Retina Associates of Utah PC
  • Oftalmólogos Especialistas
  • Calgary Retina Consultants
  • St. Joseph's Health Care London
  • Retina Centre of Ottawa
  • Fundacion Oftalmologica Nacional
  • Clinica de Oftalmologia Sandiego
  • Clinical Hospital Osiiek, Ophthalmology Clinic
  • AXON clinical
  • Hopital Intercommunal de Creteil
  • Pole Vision Val D'Ouest
  • Centre Ophtalmologique Rabelais
  • Hopital de la Croix-Rousse
  • Centre Paradis-Monticelli
  • Centre D'exploration Ophtalmologique De L'odéon
  • Centre d'Imagerie et Laser
  • Rothschild Foundation
  • Centre Ophtalmologique Saint Exupéry
  • Universitätsklinikum Hamburg Eppendorf
  • Augenklinik der Ludwig-Maximilian Universität München
  • Augenzentrum am St. Franziskus-Hospital
  • Dept. of Ophthalmology Semmelweis University Budapest
  • Budapest Retina Associates
  • Shamir Medical Center
  • AOU Policlinico S. Orsola-Malpighi
  • P. Stradins Clinical university hospital
  • Hospital Universitario Puerta de Hierro-Majadahonda
  • Clinicade Oftalmologia Barraquer
  • Instituto Clinico Quirurgico de Oftalmologia
  • Hospital La Arruzafa
  • Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
  • Instituto Oftalmológico Gómez-Ulla
  • IMED Servicio Oftalmología
  • Rio Hortega University Hospital
  • Hospital Clínico Universitario "Lozano Blesa"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avacincaptad pegol 2 mg

Arm Description

Avacincaptad pegol 2 mg administered monthly from Month 1 to Month 17

Outcomes

Primary Outcome Measures

Adverse Events
To assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

Secondary Outcome Measures

Full Information

First Posted
September 7, 2022
Last Updated
August 16, 2023
Sponsor
IVERIC bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05536297
Brief Title
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Official Title
An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

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
Patients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.
Detailed Description
Approximately 400 patients who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham) and consent to participate will be administered monthly avacincaptad pegol 2 mg from Month 1 through Month 17 (maximum 17 total doses); or until avacincaptad pegol is commercially available. All patients will have a final follow up visit at Month 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avacincaptad pegol 2 mg
Arm Type
Experimental
Arm Description
Avacincaptad pegol 2 mg administered monthly from Month 1 to Month 17
Intervention Type
Drug
Intervention Name(s)
Avacincaptad pegol 2 mg intravitreal injection
Other Intervention Name(s)
Zimura, ARC1905
Intervention Description
Avacincaptad pegol is a complement C5 inhibitor
Primary Outcome Measure Information:
Title
Adverse Events
Description
To assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
Time Frame
Month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment. Patient must provide new written informed consent for this OLE trial prior to participation. Patient must have the ability to return for all trial visits for the duration of the 18-month trial. Exclusion Criteria: Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham), Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible. Patient did not enroll into this OLE trial within the 90 day enrollment period. Patient who is pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
IVERIC bio, Inc.
Official's Role
Study Chair
Facility Information:
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
Jacobs Retina Center at The Shiley Eye Institute USCD
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
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
Orange County Retinal Med 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 CO
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
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
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
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 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
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Center for Retina & Macula Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Consultants of Hawaii, Inc.
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Vitreo Retinal Consultants & Surgeons
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
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 Retina
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Vitreoretinal Associates PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Vitreous Surgeons of Central New York
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Retina Associates of Western NY
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Retina & Vitreous Center of Southern Oregon, PC
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
Eye Health Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Mid Atlantic Retina - Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Associates in Ophthalmology
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Retina Research of Beaufort
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
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
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Retina Research Institute of Texas, LLC
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 Center of Texas
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Retina Associates of Utah PC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Oftalmólogos Especialistas
City
Rosario
State/Province
Sante Fe
ZIP/Postal Code
S2000ANJ
Country
Argentina
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4V2
Country
Canada
Facility Name
Retina Centre of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Facility Name
Fundacion Oftalmologica Nacional
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Clinica de Oftalmologia Sandiego
City
Medellin
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Clinical Hospital Osiiek, Ophthalmology Clinic
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
AXON clinical
City
Smíchov
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Hopital Intercommunal de Creteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Pole Vision Val D'Ouest
City
Ecully
ZIP/Postal Code
69130
Country
France
Facility Name
Centre Ophtalmologique Rabelais
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Paradis-Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre D'exploration Ophtalmologique De L'odéon
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Centre d'Imagerie et Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Rothschild Foundation
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre Ophtalmologique Saint Exupéry
City
Saint Cyr sur Loire
ZIP/Postal Code
37540
Country
France
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Augenklinik der Ludwig-Maximilian Universität München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Augenzentrum am St. Franziskus-Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Dept. of Ophthalmology Semmelweis University Budapest
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Budapest Retina Associates
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Shamir Medical Center
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
AOU Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
P. Stradins Clinical university hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinicade Oftalmologia Barraquer
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
Instituto Clinico Quirurgico de Oftalmologia
City
Bilbao
ZIP/Postal Code
48010
Country
Spain
Facility Name
Hospital La Arruzafa
City
Cordoba
ZIP/Postal Code
14003
Country
Spain
Facility Name
Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
City
Sant Cugat del Valles
ZIP/Postal Code
08195
Country
Spain
Facility Name
Instituto Oftalmológico Gómez-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

12. IPD Sharing Statement

Learn more about this trial

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

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