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A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (CEDAR)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abicipar Pegol
Ranibizumab
Sham Procedure
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of age-related macular degeneration in at least 1 eye
  • Best corrected visual acuity of 20/40 to 20/320 in the study eye
  • Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

  • History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
  • Cataract or refractive surgery in the study eye within the last 3 months

Sites / Locations

  • Retinal Research Institute, LLC
  • Associated Retina Consultants, Ltd.
  • Arizona Retina and Vitreous Consultants
  • Retina Associates Southwest, P.C.
  • The Retina Partners
  • Retina Consultants of Orange County
  • Mark B. Kislinger MD Inc.
  • Atlantis Retina Institute (Atlantis Eyecare)
  • Loma Linda University Medical Center
  • Northern California Retina Vitreous Associates Medical Group, INC.
  • Retina Institute of California
  • Doheny Vision Research
  • Orange County Retina Medical Group
  • California Retina Consultants
  • Retina Eye Specialists
  • Colorado Retina Associates
  • Retina Health Center
  • Mayo Clinic Florida
  • Florida Retina Consultants
  • Ocala Eye PA
  • Magruder Eye Institute
  • Retina Care Specialists
  • Retina Specialty Institute
  • Retina Vitreous Associates of Florida - Saint Petersburg
  • USF Eye Institute
  • Georgia Retina, P.C.
  • Marietta Eye Clinic - Main Office
  • Thomas Eye Group, PC
  • Retina Consultants of Hawaii, Inc.
  • Gailey Eye Clinic
  • Carle at the Fields
  • University Retina and Macula Associates, PC
  • Raj K. Maturi, MD, PC
  • John Kenyon American Eye Institute
  • Ochsner Health Center
  • Retina Specialists
  • The Bert M Glaser National Retina Institute
  • Lahey Medical Center
  • Kellog Eye Center - University of Michigan Health System
  • University of Minnesota
  • Sierra Eye Associates
  • Retina Associates of New Jersey
  • Capital Region Retina, PLLC
  • SUNY Downstate Medical Center
  • Long Island Vitreoretinal Consultants
  • Ophthalmic Consultants of Long Island
  • Retina Associates of Western New York
  • Island Retina
  • Carolina Eye Associates
  • Wake Forest Baptist Health Eye Center
  • Apex Eye Clinical Research
  • Lancaster Retina Specialists
  • Mid Atlantic Retina
  • Associates in Ophthalmology, Ltd.
  • Retina Consultants of Carolina
  • Charleston Neuroscience Institute
  • Retina Research Institute of Texas
  • Texas Retina Associates
  • Texan Eye
  • TX Retina Associates
  • Houston Eye Associates (HEA) - Gramercy Location
  • Retina and Vitreous of Texas
  • Retinal Consultants of Houston
  • San Antonio Eye Center
  • Medical Center Ophthalmology Associates
  • Retinal Consultants of San Antonio
  • Retina Consultants of Houston
  • Retina Associates of Utah
  • University of Virginia - Department of Ophthalmology
  • Piedmont Eye Center, Inc.
  • Retina Institute of Virginia
  • Clinica Privada Kaufer Cataract Center
  • Hospital Universitario Austral
  • Centro Oftalmologico Rosario SRL
  • Grupo Laser Vision
  • Organizacion Medica de Investigacion
  • Instituto Oftalmologico de Buenos Aires - Oftalmos
  • Centro Privado de Ojos Romagosa
  • Instituto Oftalmologico de Cordoba
  • Oftar Centro Privado de Oftalmologia
  • Medical University Graz
  • Medizinische Universitat Innsbruck, Univ.
  • Kepler Universitatsklinikum GmBH
  • Konventhospital Barmherzige Brueder Linz
  • KYDOFT
  • Instituto Oftalmologica Profesor Arentsen
  • Centro Medico Imbanaco
  • Fundacion Oftalmologica Nacional - FUNDONAL
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
  • Vseobecna fakultni nemocnice v Praze Ocni Klinika
  • Hopital Pellegrin
  • Centre Hospitalier Intercommunal de Creteil
  • Hopital de la Croix Rousse, Service d'Opthalmologie
  • CHU de Nantes
  • Centre Ophtalmologique d'Imagerie et de Laser
  • Centre Ophtalmologique Saint Exupery
  • Dardenne Eye Hospital
  • Klinikum Dresden Friedrichstadt
  • Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
  • Eye Center, University of Freiburg
  • Universitats-augenklinik Gottingen
  • Stadtisches Klinikum
  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
  • Universitätsklinikum Giessen und Marburg GmbH
  • Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
  • Clinic and policlinic of ophthalmology, University of Regensburg
  • The University of Hong Kong
  • The Chinese University of Hong Kong Hongkong eye hospital
  • Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
  • Rambam Health Care Campus
  • Carmel Medical Center Ophthalmology Clinic
  • Edith Wolfson Medical Center
  • Meir Medical Center
  • Rabin Medical Center Beilinson Hospital
  • Kaplan Medical Center
  • TASMC (The Tel-Aviv Sourasky Medical Centre)
  • Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
  • Shamir Medical Centre
  • Seoul National University Bundang Hospital
  • The Catholic Univ. Of Seoul St. Mary's Hospital
  • Asan Medical Center
  • Seoul National University Hospital
  • Yonsei University Health System Serverance Hospital
  • Pauls Stradins Clinical University Hospital Opthalmology Clinic
  • Auckland Eye
  • University of Auckland
  • Cebu Doctors University Hospital
  • Asian Eye Institute
  • Pacific Eyecare and Laser Institute
  • The Medical City
  • St. Luke's Medical Center
  • National University Hospital
  • Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
  • Centro de Oftalmologia Barraquer
  • Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
  • Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
  • Hospital Universitario de Bellvitge
  • Valles Oftalmologia Research Hospital
  • Instituto Clínico Quirúrgico de Oftalmología (ICQO)
  • Hospital Clinico San Carlos
  • Clinica Universidad de Navarra Servicio de Oftalmologia
  • Hospital General de Valencia Unidad de Investigacion Clinica
  • Hospital Universitari i Politecnic La Fe
  • Hospital Clinico Universitario
  • Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
  • Hospital Miguel Servet
  • Universitatsklinik fur Augenheilkunde, Inselspital
  • VISTA Klinik Binningen
  • Stiftung für wissenschaftliche Forschung am Stadtspital Triemli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Abicipar Pegol 2 mg (2Q8)

Abicipar Pegol 2 mg (2Q12)

Ranibizumab 0.5 mg (rQ4)

Arm Description

Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.

Outcomes

Primary Outcome Measures

Percentage of Participants With Stable Vision at Week 52
Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.

Secondary Outcome Measures

Mean Change From Baseline in BCVA in the Study Eye at Week 52
BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.

Full Information

First Posted
June 2, 2015
Last Updated
July 16, 2020
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02462928
Brief Title
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Acronym
CEDAR
Official Title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 25, 2015 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

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
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
939 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abicipar Pegol 2 mg (2Q8)
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Arm Title
Abicipar Pegol 2 mg (2Q12)
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Arm Title
Ranibizumab 0.5 mg (rQ4)
Arm Type
Active Comparator
Arm Description
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Intervention Type
Drug
Intervention Name(s)
Abicipar Pegol
Other Intervention Name(s)
AGN-150998
Intervention Description
Abicipar pegol intravitreal injection.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab intravitreal injection.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
Sham injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With Stable Vision at Week 52
Description
Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame
Baseline to Week 52
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in BCVA in the Study Eye at Week 52
Description
BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Time Frame
Baseline to Week 52
Title
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Description
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.
Time Frame
Baseline to Week 52
Title
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
Description
BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame
Baseline to Week 52
Title
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Description
NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of age-related macular degeneration in at least 1 eye Best corrected visual acuity of 20/40 to 20/320 in the study eye Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: History of vitrectomy, macular surgery, or glaucoma surgery in the study eye Cataract or refractive surgery in the study eye within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Li
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Retina and Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Retina Associates Southwest, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Mark B. Kislinger MD Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Atlantis Retina Institute (Atlantis Eyecare)
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Northern California Retina Vitreous Associates Medical Group, INC.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Institute of California
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Doheny Vision Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Retina Eye Specialists
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Ocala Eye PA
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Magruder Eye Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
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 - Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
USF Eye Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Retina, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Marietta Eye Clinic - Main Office
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Thomas Eye Group, PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Retina Consultants of Hawaii, Inc.
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Gailey Eye Clinic
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Carle at the Fields
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61822
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
Raj K. Maturi, MD, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
John Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Ochsner Health Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Retina Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
The Bert M Glaser National Retina Institute
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Lahey Medical Center
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Kellog Eye Center - University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Associates of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Capital Region Retina, PLLC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
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 New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Island Retina
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Wake Forest Baptist Health Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Apex Eye Clinical Research
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Lancaster Retina Specialists
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
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 Consultants of Carolina
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
TX Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Eye Associates (HEA) - Gramercy Location
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Retina and Vitreous of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Retinal Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Retina Associates of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia - Department of Ophthalmology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Piedmont Eye Center, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Clinica Privada Kaufer Cataract Center
City
Martinez
State/Province
Buenos Aires
ZIP/Postal Code
B1640BNT
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Centro Oftalmologico Rosario SRL
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000ANJ
Country
Argentina
Facility Name
Grupo Laser Vision
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000AZH
Country
Argentina
Facility Name
Organizacion Medica de Investigacion
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Instituto Oftalmologico de Buenos Aires - Oftalmos
City
Buenos Aires
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Centro Privado de Ojos Romagosa
City
Cordoba
ZIP/Postal Code
X5000AAJ
Country
Argentina
Facility Name
Instituto Oftalmologico de Cordoba
City
Cordoba
ZIP/Postal Code
X5000IIT
Country
Argentina
Facility Name
Oftar Centro Privado de Oftalmologia
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitat Innsbruck, Univ.
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kepler Universitatsklinikum GmBH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Konventhospital Barmherzige Brueder Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
KYDOFT
City
Santiago
State/Province
Las Condes
ZIP/Postal Code
7560994
Country
Chile
Facility Name
Instituto Oftalmologica Profesor Arentsen
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7510168
Country
Chile
Facility Name
Centro Medico Imbanaco
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fundacion Oftalmologica Nacional - FUNDONAL
City
Bogota
Country
Colombia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze Ocni Klinika
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Intercommunal de Creteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital de la Croix Rousse, Service d'Opthalmologie
City
Lyon cedex 04
ZIP/Postal Code
69417
Country
France
Facility Name
CHU de Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Ophtalmologique d'Imagerie et de Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Ophtalmologique Saint Exupery
City
Saint Cyr sur Loire
ZIP/Postal Code
37540
Country
France
Facility Name
Dardenne Eye Hospital
City
Bad Godesberg
ZIP/Postal Code
53177
Country
Germany
Facility Name
Klinikum Dresden Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
City
Dusseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Eye Center, University of Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitats-augenklinik Gottingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Stadtisches Klinikum
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
City
Neubrandenburg
ZIP/Postal Code
17036
Country
Germany
Facility Name
Clinic and policlinic of ophthalmology, University of Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
The University of Hong Kong
City
Aberdeen
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong Hongkong eye hospital
City
Kowloon
Country
Hong Kong
Facility Name
Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center Ophthalmology Clinic
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
TASMC (The Tel-Aviv Sourasky Medical Centre)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Shamir Medical Centre
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
The Catholic Univ. Of Seoul St. Mary's Hospital
City
Seocho
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Health System Serverance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital Opthalmology Clinic
City
Riga
State/Province
LV
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Auckland Eye
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
University of Auckland
City
Auckland
ZIP/Postal Code
1123
Country
New Zealand
Facility Name
Cebu Doctors University Hospital
City
Cebu City
State/Province
Metro Manila
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Asian Eye Institute
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pacific Eyecare and Laser Institute
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1209
Country
Philippines
Facility Name
The Medical City
City
Pasig City
State/Province
Metro Manila
ZIP/Postal Code
1600
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1102
Country
Philippines
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Centro de Oftalmologia Barraquer
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Valles Oftalmologia Research Hospital
City
Barcelona
ZIP/Postal Code
08915
Country
Spain
Facility Name
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
City
Bilbao
ZIP/Postal Code
48006
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Universidad de Navarra Servicio de Oftalmologia
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General de Valencia Unidad de Investigacion Clinica
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitatsklinik fur Augenheilkunde, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
VISTA Klinik Binningen
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Facility Name
Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland

12. IPD Sharing Statement

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A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

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