Actively Recruiting
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Led by Hoffmann-La Roche · Updated on 2026-04-27
1000
Participants Needed
165
Research Sites
579 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous enrollment and completion of Study GX28228 (Ladder) or Study GR40548 (Archway) without early treatment or discontinuation, OR previous enrollment in Study WR42221 (Velodrome) with eligibility criteria met
- Ability and willingness to complete all scheduled visits and assessments
- For women of childbearing potential: agree to abstain or use contraception
- For sub-study 1: diagnosis of exudative nAMD within 2 years before enrollment
- Prior treatment with at least two anti-VEGF intravitreal injections within 6 months before enrollment
- Demonstrated response to prior anti-VEGF treatment with decreased disease activity and stable or improved vision
- Clear ocular media and adequate pupil dilation for imaging analysis
- For sub-study 2: experienced septum dislodgement in original implant and clear ocular media with adequate pupil dilation
You will not qualify if you...
- Pregnant, breastfeeding, or intending pregnancy during treatment and for at least 28 days after last ranibizumab injection or 1 year after last implant refill
- History of ocular diseases or conditions that contraindicate ranibizumab use or implant placement or increase risk of complications
- Prior ocular surgeries including vitrectomy, submacular surgery, or laser treatments for AMD
- Use of corticosteroid intravitreal injections or other intraocular devices prior to enrollment
- Recent treatment with anti-VEGF agents other than ranibizumab within 1 month before enrollment
- Subretinal hemorrhage involving the fovea greater than 0.5 disc area
- Concurrent ocular conditions requiring surgery or affecting safety or study interpretation
- Active intraocular inflammation or infections
- History of glaucoma surgeries or uncontrolled ocular hypertension
- Systemic conditions including uncontrolled blood pressure, recent stroke, myocardial infarction, atrial fibrillation, active infection, active cancer within 12 months, or current systemic anti-VEGF treatment
- Use of antimitotic or antimetabolite therapy within 30 days or 5 half-lives before enrollment
- Inability to comply with study schedule or procedures
- Recent participation in other investigational drug trials excluding vitamins and minerals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 165 locations
1
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85014
Completed
2
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States, 85016
Completed
3
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
Active, Not Recruiting
4
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Completed
5
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85053
Completed
6
California Retina Consultants
Bakersfield, California, United States, 93309
Completed
7
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Completed
8
The Retina Partners
Encino, California, United States, 91436
Active, Not Recruiting
9
Jacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California, United States, 92037
Completed
10
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States, 90095-7000
Completed
11
N CA Retina Vitreous Assoc
Mountain View, California, United States, 94040
Completed
12
Retina Consultants, San Diego
Poway, California, United States, 92064
Completed
13
Retinal Consultants Med Group
Sacramento, California, United States, 95841
Completed
14
West Coast Retina Medical Group
San Francisco, California, United States, 94109
Completed
15
UCSF
San Francisco, California, United States, 94158
Completed
16
Orange County Retina Med Group
Santa Ana, California, United States, 92705
Completed
17
California Retina Consultants
Santa Barbara, California, United States, 93103
Completed
18
Southwest Retina Consultants
Durango, Colorado, United States, 81303
Completed
19
Eye Center of Northern CO
Fort Collins, Colorado, United States, 80528
Completed
20
Colorado Retina Associates, PC
Lakewood, Colorado, United States, 80228
Completed
21
Retina Group of New England
Waterford, Connecticut, United States, 06385
Completed
22
Florida Eye Microsurgical Inst
Boynton Beach, Florida, United States, 33426
Completed
23
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Completed
24
Florida Eye Associates
Melbourne, Florida, United States, 32901
Completed
25
Retina Care Specialists
Palm Beach Gardens, Florida, United States, 33410
Completed
26
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Completed
27
Fort Lauderdale Eye Institute
Plantation, Florida, United States, 33324
Completed
28
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States, 33711
Active, Not Recruiting
29
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States, 32308
Active, Not Recruiting
30
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609
Completed
31
Southeast Retina Center
Augusta, Georgia, United States, 30909
Completed
32
Georgia Retina PC
Marietta, Georgia, United States, 30060
Withdrawn
33
Illinois Retina Associates
Joliet, Illinois, United States, 60435
Completed
34
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States, 60452
Completed
35
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
Completed
36
Retina Associates
Lenexa, Kansas, United States, 66215
Completed
37
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
Completed
38
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
Withdrawn
39
Maine Eye Center
Portland, Maine, United States, 04101
Completed
40
The Retina Care Center
Baltimore, Maryland, United States, 21209
Completed
41
Johns Hopkins Med
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
42
Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
Completed
43
Retina Specialists
Towson, Maryland, United States, 21204
Completed
44
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Completed
45
Foundation for Vision Research
Grand Rapids, Michigan, United States, 49546
Completed
46
Associated Retinal Consultants
Royal Oak, Michigan, United States, 48073
Completed
47
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States, 55435
Completed
48
Midwest Vision Research Foundation
Chesterfield, Missouri, United States, 63017
Completed
49
The Retina Institute - Chesterfield
St Louis, Missouri, United States, 63128
Completed
50
Sierra Eye Associates
Reno, Nevada, United States, 89502
Completed
51
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Completed
52
Retina Associates of NJ
Teaneck, New Jersey, United States, 07666
Completed
53
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Completed
54
Long Is. Vitreoretinal Consult
Great Neck, New York, United States, 11021
Completed
55
Retina Assoc of Western NY
Rochester, New York, United States, 14620
Completed
56
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
Completed
57
Retina Vit Surgeons/Central NY
Syracuse, New York, United States, 13224
Completed
58
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States, 28210
Completed
59
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Completed
60
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Completed
61
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States, 43212
Active, Not Recruiting
62
Retina Vitreous Center
Edmond, Oklahoma, United States, 73013
Completed
63
Retina Northwest
Portland, Oregon, United States, 97221
Completed
64
Oregon HSU
Portland, Oregon, United States, 97239
Completed
65
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Completed
66
Palmetto Retina Center
Florence, South Carolina, United States, 29501
Completed
67
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States, 29169
Completed
68
Charles Retina Institute
Germantown, Tennessee, United States, 38138
Completed
69
Tennessee Retina PC
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
70
Texas Retina Associates
Arlington, Texas, United States, 76012
Completed
71
Austin Retina Associates
Austin, Texas, United States, 78705
Completed
72
Austin Clinical Research LLC
Austin, Texas, United States, 78750
Active, Not Recruiting
73
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Completed
74
Texas Retina Associates
Fort Worth, Texas, United States, 76104
Completed
75
Med Center Ophthalmology Assoc
San Antonio, Texas, United States, 78240
Completed
76
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Completed
77
Retina Associates of Utah, PLLC
Salt Lake City, Utah, United States, 84107
Completed
78
Rocky Mountain Retina
Salt Lake City, Utah, United States, 84107
Completed
79
Wagner Kapoor Institute
Virginia Beach, Virginia, United States, 23454
Completed
80
Pacific Northwest Retina
Silverdale, Washington, United States, 98383
Completed
81
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Completed
82
Oftalmos
Capital Federal, Argentina, C1120AAN
Actively Recruiting
83
Centro Oftalmologico Dr. Charles S.A.
Ciudad Autonoma Buenos Aires, Argentina, C1121ABB
Actively Recruiting
84
Grupo Laser Vision
Rosario, Argentina, S2000DLA
Actively Recruiting
85
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia, 2640
Active, Not Recruiting
86
Eye and Retina Consultants
Hurstville, New South Wales, Australia, 2220
Actively Recruiting
87
LKH-Univ.Klinikum Graz
Graz, Austria, 8036
Actively Recruiting
88
Medizinische Universitat Wien
Vienna, Austria, 1090
Actively Recruiting
89
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Withdrawn
90
Botelho Hospital da Visao
Blumenau, Santa Catarina, Brazil, 89052-504
Actively Recruiting
91
Retina Clinic
São Paulo, São Paulo, Brazil, 01427-002
Actively Recruiting
92
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, Brazil, 04023-062
Actively Recruiting
93
Instituto da Visao IPEPO
São Paulo, São Paulo, Brazil, 04038-032
Actively Recruiting
94
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, Brazil, 18031-060
Actively Recruiting
95
Centre Retine Gallien
Bordeaux, France, 33000
Actively Recruiting
96
Hopital de la croix rousse
Lyon, France, 69317
Actively Recruiting
97
Centre Paradis Monticelli
Marseille, France, 13008
Actively Recruiting
98
Hopital Lariboisiere
Paris, France, 75010
Actively Recruiting
99
Fondation Rothschild
Paris, France, 75940
Actively Recruiting
100
Universitatsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
101
Universitatsklinikum Koln
Cologne, Germany, 50937
Actively Recruiting
102
Medizinische Universitat Lausitz ? Carl Thiem
Cottbus, Germany, 03048
Actively Recruiting
103
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
104
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
105
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, Germany, 67063
Actively Recruiting
106
LMU Klinikum der Universitat, Augenklinik
München, Germany, 80336
Actively Recruiting
107
Augenabteilung am St. Franziskus-Hospital
Münster, Germany, 48145
Actively Recruiting
108
Universitatsklinikum Munster
Münster, Germany, 48149
Actively Recruiting
109
Knappschaftsklinikum Saar GmbH
Sulzbach, Germany, 66280
Actively Recruiting
110
Universitatsklinikum Tubingen
Tübingen, Germany, 72076
Actively Recruiting
111
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, Germany, 89075
Actively Recruiting
112
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
113
Hadassah MC
Jerusalem, Israel, 9112001
Actively Recruiting
114
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
115
Rabin MC
Petah Tikva, Israel, 4941492
Actively Recruiting
116
Kaplan Medical Center
Rehovot, Israel, 7660101
Actively Recruiting
117
Tel Aviv Sourasky MC
Tel Aviv, Israel, 6423906
Actively Recruiting
118
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, Italy, 66100
Actively Recruiting
119
Policlinico di Bari
Bari, Apulia, Italy, 70124
Actively Recruiting
120
Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore
Trieste, Friuli Venezia Giulia, Italy, 34129
Actively Recruiting
121
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy, 00168
Actively Recruiting
122
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy, 00198
Actively Recruiting
123
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy, Italy, 20100
Actively Recruiting
124
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
125
Asst Fatebenefratelli Sacco
Milan, Lombardy, Italy, 20157
Actively Recruiting
126
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches, Italy, 60126
Actively Recruiting
127
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy, 50134
Actively Recruiting
128
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria, Italy, 06129
Actively Recruiting
129
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria
Negrar - Verona, Veneto, Italy, 37024
Actively Recruiting
130
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, Italy, 33100
Actively Recruiting
131
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
132
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain, 08195
Actively Recruiting
133
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
134
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
135
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, Spain, 33012
Actively Recruiting
136
Oftalvist Valencia
Burjassot, Valencia, Spain, 46100
Actively Recruiting
137
Centro de Oftalmologia Barraquer
Barcelona, Spain, 08021
Actively Recruiting
138
Institut de la Macula i la retina
Barcelona, Spain, 08022
Actively Recruiting
139
Hospital dos de maig
Barcelona, Spain, 08025
Completed
140
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
141
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, Spain, 14012
Actively Recruiting
142
Clinica Baviera
Madrid, Spain, 28046
Actively Recruiting
143
Universitatsspital Basel Augenklinik Klinik
Basel, Switzerland, 4056
Actively Recruiting
144
Inselspital Bern Ophthalmologische Klinik
Bern, Switzerland, 3010
Actively Recruiting
145
Vista Klinik Ophthalmologische Klinik
Binningen, Switzerland, 4102
Active, Not Recruiting
146
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
Lausanne, Switzerland
Actively Recruiting
147
Stadtspital Triemli Ophthalmologische Klinik
Zurich, Switzerland, 8063
Active, Not Recruiting
148
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
149
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
150
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
151
Chang Gung Medical Foundation - Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
152
National Taiwan University Hospital
Zhongzheng Dist., Taiwan, 10002
Actively Recruiting
153
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
154
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 06490
Actively Recruiting
155
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye), DUMMY_VALUE
Actively Recruiting
156
Beyoglu Goz Training and Research Hospital
Istanbul, Turkey (Türkiye), 34421
Actively Recruiting
157
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
158
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX
Actively Recruiting
159
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Active, Not Recruiting
160
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Active, Not Recruiting
161
Central Middlesex Hospital
London, United Kingdom, NW10 7NS
Actively Recruiting
162
Kings College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Active, Not Recruiting
163
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
164
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Actively Recruiting
165
Royal Wolverhampton hospital
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
R
Reference Study ID Number: GR40549 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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