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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02462928
Recruitment Status : Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: abicipar pegol Drug: ranibizumab Other: sham procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 939 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : April 18, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: abicipar pegol 2 mg (group A)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 8, followed by injections every 8 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.

Other: sham procedure
Sham procedure to the study eye at the visits noted per protocol.

Experimental: abicipar pegol 2 mg (group B)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 12, followed by injections every 12 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.

Other: sham procedure
Sham procedure to the study eye at the visits noted per protocol.

Active Comparator: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
Drug: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
Other Name: Lucentis®




Primary Outcome Measures :
  1. Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Week 52 ]
  2. Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 52 ]
  3. Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale [ Time Frame: Baseline, Week 52 ]
  4. Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score [ Time Frame: Baseline, Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462928


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Locations
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United States, Arizona
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85014
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States, 85020
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States, 85021
Retina Associates Southwest, OC
Tucson, Arizona, United States, 85710
United States, California
The Retina Partners
Encino, California, United States, 91436
Retina Consultants of Orange County
Fullerton, California, United States, 92835
Mark B. Kislinger, MD, PhD, Inc.
Glendora, California, United States, 91741
Atlantis Eye Care
Huntington Beach, California, United States, 92647
Loma Linda University
Loma Linda, California, United States, 92354
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Retina Institute of California
Palm Desert, California, United States, 92260
Retina Eye Specialists
Pasadena, California, United States, 91030
Doheny Vision Research
Pasadena, California, United States, 91105
Orange County Retina Medical Group
Santa Ana, California, United States, 92705
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Colorado
Colorado Retina Associates, PC
Golden, Colorado, United States, 80401
United States, Florida
Retina Health Center
Fort Myers, Florida, United States, 33907
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Florida Retina Consultants
Lakeland, Florida, United States, 33805
Ocala Eye PA
Ocala, Florida, United States, 34474
Magruder Eye Institute
Orlando, Florida, United States, 32803
Retina Care Specialists
Palm Beach Gardens, Florida, United States, 33410
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Retina Vitreous Associates of Florida - Saint Petersburg
Saint Petersburg, Florida, United States, 33711
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Marietta Eye Clinic
Marietta, Georgia, United States, 30060-8934
Georgia Retina, P.C.
Marietta, Georgia, United States, 30060
Thomas Eye Group, PC
Sandy Springs, Georgia, United States, 30328
United States, Hawaii
Retina Consultants of Hawaii, Inc.
'Aiea, Hawaii, United States, 96701
United States, Illinois
Gailey Eye Clinic
Bloomington, Illinois, United States, 61701
University Retina and Macula Associates
Oak Forest, Illinois, United States, 60439
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Raj K. Maturi, M.D., P.C
Indianapolis, Indiana, United States, 46290
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
United States, Louisiana
Ochsner Health Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
National Retina Institute
Towson, Maryland, United States, 21204
Retina Specialists
Towson, Maryland, United States, 21204
United States, Massachusetts
Lahey Clinic Medical Center
Peabody, Massachusetts, United States, 01960
United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, New Jersey
Retina Associates of New Jersey
Teaneck, New Jersey, United States, 07666
United States, New York
Capital Region Retina, PLLC
Albany, New York, United States, 12206
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11201
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
Ophthalmic Consultants Long Island
Lynbrook, New York, United States, 11563
Retina Associates of Western NY
Rochester, New York, United States, 14620
Island Retina
Shirley, New York, United States, 11967
United States, North Carolina
Carolina Eye Associates
Southern Pines, North Carolina, United States, 28387
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Apex Eye Clinical Research
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Lancaster Retina Specialists
Lancaster, Pennsylvania, United States, 17601
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Associates in Ophthalmalogy
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Retina Consultants of Carolina
Greenville, South Carolina, United States, 29605
Charleston Neuroscience Institute
Ladson, South Carolina, United States, 29456
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Texas Retina Associates
Arlington, Texas, United States, 76012
Texan Eye Care
Austin, Texas, United States, 78731
Texas Retina Associates
Dallas, Texas, United States, 75231
Houston Eye Associates
Houston, Texas, United States, 77025
Retina and Vitreous of Texas
Houston, Texas, United States, 77025
Retinal Consultants of Houston
Houston, Texas, United States, 77030
San Antonio Eye Center
San Antonio, Texas, United States, 78215
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
United States, Utah
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Piedmont Eye Center, Inc.
Lynchburg, Virginia, United States, 24502
Retina Institute of Virginia
Richmond, Virginia, United States, 23235
Argentina
Hospital Universitario Austral
Buenos Aires, Argentina, B1629ODT
Kaufer Eye Clinic
Buenos Aires, Argentina, B1640BNT
Organizacion Medica de Investigacion
Buenos Aires, Argentina, C1015ABO
Oftalmos
Buenos Aires, Argentina, C1120AAN
Centro Privado de Ojos Romagosa
Cordoba, Argentina, 5000
Instituto Oftalmologico de Cordoba
Cordoba, Argentina, X5000IIT
Oftar Centro Privado de Oftalmologia
Mendoza, Argentina, 5500
Oftalmologos Especialistas
Santa Fe, Argentina, S2000ANJ
Grupo Laser Vision
Santa Fe, Argentina, S2000AZUH
Austria
University of Graz
Graz, Austria, A-8036
Universitatsklinikum Innsbruck
Innsbruck, Austria, 6020
AKH Linz Augenheilkunde
Linz, Austria, 4021
Konventhospital der Barmherzigen Brüder
Linz, Austria, 4021
Chile
Instituto Oftalmologica Profesor Arentsen
Santiago, Región Metropolitana, Chile, 7510168
KYDOFT - Hospital
Santiago, Región Metropolitana, Chile, 765-0021
Colombia
Fundacion Oftalmologica Nacional
Bogotá, Cundinamarca, Colombia
Centro Medico Imbanaco
Cali, Valle Del Cauca, Colombia, 760042
Czechia
University Hospital Brno
Brno, Czechia, 62500
I.P. Pavlova 6, Olomouc
Olomouc, Czechia, 77520
The Eye Department Oční klinika
Prague 10, Czechia, 100 34
General University Hospital - Clinic of Ophthalmology
Prague 2, Czechia, 12808
France
Hopital Pellegrin
Bordeaux, France, 33076
Centre Hospitalier Intercommunal de Creteil
Creteil, France, 94010
Hopital de la Croix-Rousse
Lyon cedex 04, France, 69317
Centre Hospitailier Universitaire de Nantes
Nantes Cedex 1, France, 44 093
Centre Ophtalmo Imagerie (C.I.L)
Paris, France, 75015
Centre Ophtalmologique Transparence
Tours, France, 37000
Germany
Augenklinik Dardenne SE
Bonn, Germany, 53177
Klinikum Dresden Friedrichstadt
Dresden, Germany, 01067
Augenchirurgie fur den Bereich Makula
Dusseldorf, Germany, 40212
Universitat Augenklinik
Freiburg, Germany, 79106
Universitatsaugenklinik Gottingen
Goettingen, Germany, 37075
Staedtisches Klinikum
Karlsruhe, Germany, 76133
Augenklinik der Universität Leipzig
Leipzig, Germany, 04103
Universitätsklinikum Giessen und Marburg GmbH
Marburg, Germany, 35043
Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, Germany, 17036
Klinikum d. Universitat Regensburg
Regensburg, Germany, 93042
Hong Kong
Hong Kong Eye Hospital
Kowloon, Hong Kong
The University of Hong Kong
Pok Fu Lam, Hong Kong
Israel
Assaf Harofeh Medical Center
Beer-Yaakov, Israel, 70300
Bnai Zion M.C.
Haifa, Israel, 31048
Rambam Medical Center
Haifa, Israel, 31096
Carmel Medical Center
Haifa, Israel, 34362
Wolfson Hospital
Holon, Israel, 58100
Meir Medical Center
Kfar-Saba, Israel, 44281
Rabin Medical Center Beilinson Hospital
Petach Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
The Goldschleger Eye Institute
Tel Hashomer, Israel, 52621
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of, 03080
The Catholic University of Korea
Jongno-gu, Seoul, Korea, Republic of, 14647
Severance Hospital, Yonsei University Health System
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 05505
Latvia
Paula Stradina Kliniiskas Universitates Slimnica
Riga, Latvia, LV-1002
New Zealand
Auckland Eye Hospital
Remuera, Auckland N, New Zealand, 1051
The University of Auckland
Auckland, New Zealand, 1142
Philippines
Cebu Doctors' University Hospital
Cebu City, Metro Manila, Philippines, 6000
Asian Eye Institute
Makati City, Metro Manila, Philippines, 1200
Pacific Eyecare & Laser Institute
Makati City, Metro Manila, Philippines, 1209
The Medical City
Pasig City, Metro Manila, Philippines, 1601
St. Luke's Medical Center
Quezon City, Metro Manila, Philippines, 1102
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore National Eye Centre
Singapore, Singapore, 168251
Spain
Bellvitge University Hopsital
L'hospitalet de Llobregat, Barcelona, Spain, 08800
ICQO
Bilbao, Bizkaia, Spain, 48006
Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Centro de Oftalmologia Barraquer
Barcelona, Spain, 08021
ICOF Hospital Clinic De Barcelona
Barcelona, Spain, 08028
Valles Oftalmologia Recerca
Barcelona, Spain, 08195
Instituto de Microcirugía Ocular
Barcelona, Spain, 8035
Hospital Clinico San Carl
Madrid, Spain, 28040
Hospital de la Fe
Valencia, Spain, 46009
Hospital General
Valencia, Spain, 46017
Instituti U. de Oftalmologia Aplicade-Facultad de Med.
Valladolid, Spain, 47005
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Switzerland
University Eye Hospital Bern
Bern, Switzerland, CH-3010
Vista Klinik AG
Binningen, Switzerland, 4102
Stadtspital Triemli Ophthalmology
Zurich, Switzerland, 8063
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Bill Bunnell, Ph.D. Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02462928     History of Changes
Other Study ID Numbers: 150998-005
2014-004579-22 ( EudraCT Number )
CEDAR ( Other Identifier: Allergan )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents