Extension Study for the Port Delivery System With Ranibizumab (Portal)
Start Date
9/20/2018
Completion Date
12/31/2029
Summary
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
Detailed Description
The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
PDS Implant with Ranibizumab 100 mg/mL
Conditions
Locations
Retinal Research Institute, LLC
Phoenix, Arizona 85014
United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona 85016
United States
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona 85016
United States
Associated Retina Consultants
Phoenix, Arizona 85020
United States
Retinal Consultants of Arizona
Phoenix, Arizona 85053
United States
California Retina Consultants
Bakersfield, California 93309
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
The Retina Partners
Encino, California 91436
United States
Jacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California 92037
United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California 90095-7000
United States
N CA Retina Vitreous Assoc
Mountain View, California 94040
United States
Retina Consultants, San Diego
Poway, California 92064
United States
Retinal Consultants Med Group
Sacramento, California 95841
United States
West Coast Retina Medical Group
San Francisco, California 94109
United States
UCSF
San Francisco, California 94158
United States
Orange County Retina Med Group
Santa Ana, California 92705
United States
California Retina Consultants
Santa Barbara, California 93103
United States
Southwest Retina Consultants
Durango, Colorado 81303
United States
Eye Center of Northern CO
Fort Collins, Colorado 80528
United States
Colorado Retina Associates, PC
Lakewood, Colorado 80228
United States
Retina Group of New England
Waterford, Connecticut 06385
United States
Florida Eye Microsurgical Inst
Boynton Beach, Florida 33426
United States
National Ophthalmic Research Institute
Fort Myers, Florida 33912
United States
Florida Eye Associates
Melbourne, Florida 32901
United States
Retina Care Specialists
Palm Beach Gardens, Florida 33410
United States
Retina Specialty Institute
Pensacola, Florida 32503
United States
Fort Lauderdale Eye Institute
Plantation, Florida 33324
United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida 33711
United States
Southern Vitreoretinal Assoc
Tallahassee, Florida 32308
United States
Retina Associates of Florida, LLC
Tampa, Florida 33609
United States
Southeast Retina Center
Augusta, Georgia 30909
United States
Georgia Retina PC
Marietta, Georgia 30060
United States
Illinois Retina Associates
Joliet, Illinois 60435
United States
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United States
Wolfe Eye Clinic
West Des Moines, Iowa 50266
United States
Retina Associates
Lenexa, Kansas 66215
United States
Retina Associates of Kentucky
Lexington, Kentucky 40509
United States
Paducah Retinal Center
Paducah, Kentucky 42001
United States
Maine Eye Center
Portland, Maine 04101
United States
The Retina Care Center
Baltimore, Maryland 21209
United States
Johns Hopkins Med
Baltimore, Maryland 21287
United States
Retina Group of Washington
Chevy Chase, Maryland 20815
United States
Retina Specialists
Towson, Maryland 21204
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United States
Foundation for Vision Research
Grand Rapids, Michigan 49546
United States
Associated Retinal Consultants
Royal Oak, Michigan 48073
United States
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota 55435
United States
Midwest Vision Research Foundation
Chesterfield, Missouri 63017
United States
The Retina Institute - Chesterfield
St Louis, Missouri 63128
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United States
Retina Associates of NJ
Teaneck, New Jersey 07666
United States
University of New Mexico
Albuquerque, New Mexico 87131
United States
Long Is. Vitreoretinal Consult
Great Neck, New York 11021
United States
Retina Assoc of Western NY
Rochester, New York 14620
United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York 11570
United States
Retina Vit Surgeons/Central NY
Syracuse, New York 13224
United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina 28210
United States
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
OSU Eye Physicians & Surgeons
Columbus, Ohio 43212
United States
Retina Vitreous Center
Edmond, Oklahoma 73013
United States
Retina Northwest
Portland, Oregon 97221
United States
Oregon HSU
Portland, Oregon 97239
United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania 19107
United States
Palmetto Retina Center
Florence, South Carolina 29501
United States
Palmetto Retina Center, LLC
West Columbia, South Carolina 29169
United States
Charles Retina Institute
Germantown, Tennessee 38138
United States
Tennessee Retina PC
Nashville, Tennessee 37203
United States
Texas Retina Associates
Arlington, Texas 76012
United States
Austin Retina Associates
Austin, Texas 78705
United States
Austin Clinical Research LLC
Austin, Texas 78750
United States
Retina Consultants of Texas
Bellaire, Texas 77401
United States
Texas Retina Associates
Fort Worth, Texas 76104
United States
Med Center Ophthalmology Assoc
San Antonio, Texas 78240
United States
Retina Consultants of Texas
The Woodlands, Texas 77384
United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah 84107
United States
Rocky Mountain Retina
Salt Lake City, Utah 84107
United States
Wagner Kapoor Institute
Virginia Beach, Virginia 23454
United States
Pacific Northwest Retina
Silverdale, Washington 98383
United States
Spokane Eye Clinical Research
Spokane, Washington 99204
United States
Oftalmos
Capital Federal, C1120AAN
Argentina
Centro Oftalmologico Dr. Charles S.A.
Ciudad Autonoma Buenos Aires, C1121ABB
Argentina
Grupo Laser Vision
Rosario, S2000DLA
Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales 2640
Australia
Eye and Retina Consultants
Hurstville, New South Wales 2220
Australia
LKH-Univ.Klinikum Graz
Graz, 8036
Austria
Medizinische Universitat Wien
Vienna, 1090
Austria
UZ Leuven Gasthuisberg
Leuven, 3000
Belgium
Botelho Hospital da Visao
Blumenau, Santa Catarina 89052-504
Brazil
Retina Clinic
São Paulo, São Paulo 01427-002
Brazil
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo 04023-062
Brazil
Instituto da Visao IPEPO
São Paulo, São Paulo 04038-032
Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo 18031-060
Brazil
Centre Retine Gallien
Bordeaux, 33000
France
Hopital de la croix rousse
Lyon, 69317
France
Centre Paradis Monticelli
Marseille, 13008
France
Hopital Lariboisiere
Paris, 75010
France
Fondation Rothschild
Paris, 75940
France
Universitatsklinikum Bonn
Bonn, 53127
Germany
Universitatsklinikum Koln
Cologne, 50937
Germany
Medizinische Universitat Lausitz ? Carl Thiem
Cottbus, 03048
Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106
Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
Germany
LMU Klinikum der Universitat, Augenklinik
München, 80336
Germany
Augenabteilung am St. Franziskus-Hospital
Münster, 48145
Germany
Universitatsklinikum Munster
Münster, 48149
Germany
Knappschaftsklinikum Saar GmbH
Sulzbach, 66280
Germany
Universitatsklinikum Tubingen
Tübingen, 72076
Germany
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, 89075
Germany
Rambam Medical Center
Haifa, 3109601
Israel
Hadassah MC
Jerusalem, 9112001
Israel
Meir Medical Center
Kfar Saba, 4428164
Israel
Rabin MC
Petah Tikva, 4941492
Israel
Kaplan Medical Center
Rehovot, 7660101
Israel
Tel Aviv Sourasky MC
Tel Aviv, 6423906
Israel
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo 66100
Italy
Policlinico di Bari
Bari, Apulia 70124
Italy
Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore
Trieste, Friuli Venezia Giulia 34129
Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio 00168
Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio 00198
Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy 20100
Italy
Irccs Ospedale San Raffaele
Milan, Lombardy 20132
Italy
Asst Fatebenefratelli Sacco
Milan, Lombardy 20157
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches 60126
Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany 50134
Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria 06129
Italy
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria
Negrar - Verona, Veneto 37024
Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto 33100
Italy
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona 08195
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
Spain
Clinica Universitaria de Navarra
Pamplona, Navarre 31008
Spain
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias 33012
Spain
Oftalvist Valencia
Burjassot, Valencia 46100
Spain
Centro de Oftalmologia Barraquer
Barcelona, 08021
Spain
Institut de la Macula i la retina
Barcelona, 08022
Spain
Hospital dos de maig
Barcelona, 08025
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, 14012
Spain
Clinica Baviera
Madrid, 28046
Spain
Universitatsspital Basel Augenklinik Klinik
Basel, 4056
Switzerland
Inselspital Bern Ophthalmologische Klinik
Bern, 3010
Switzerland
Vista Klinik Ophthalmologische Klinik
Binningen, 4102
Switzerland
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
Lausanne,
Switzerland
Stadtspital Triemli Ophthalmologische Klinik
Zurich, 8063
Switzerland
Changhua Christian Hospital
Changhua, 500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City,
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
Taiwan
National Taiwan University Hospital
Zhongzheng Dist., 10002
Taiwan
Hacettepe University Medical Faculty
Ankara, 06100
Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06490
Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, DUMMY_VALUE
Turkey (Türkiye)
Beyoglu Goz Training and Research Hospital
Istanbul, 34421
Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380
Turkey (Türkiye)
Bristol Eye Hospital
Bristol, BS1 2LX
United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
United Kingdom
Central Middlesex Hospital
London, NW10 7NS
United Kingdom
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP
United Kingdom
Royal Wolverhampton hospital
Wolverhampton, WV10 0QP
United Kingdom