Neovascular Age-Related Macular DegenerationPhase 3PortalNCT03683251
Extension Study for the Port Delivery System With Ranibizumab (Portal)
A Phase 3 study testing PDS Implant with Ranibizumab 100 mg/mL in people with Neovascular Age-Related Macular Degeneration, run by Hoffmann-La Roche at 165 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- PDS Implant with Ranibizumab 100 mg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 165 sitesin 15 countries
- Study dates
- 20 Sep 2018to 31 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- Participants must meet the following ocular criteria for the study eye for substudy entry:
- Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
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- Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit
- Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:
- Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)
- All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).
- Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.
- Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye
- Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center
Who cannot join
- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
- History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
- History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications
- Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
- Sub-study 1
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
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- Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
- Previous treatment with corticosteroid ITV injection
- Previous intraocular device implantation
- Previous laser (any type) used for AMD treatment
- Either Eye
- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
- Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab
- CNV Lesion Charateristics Study Eye
- Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
- Subfoveal fibrosis or subfoveal atrophy
- Either Eye
- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- Concurrent Ocular Conditions Study Eye
- Retinal pigment epithelial tear
- Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
- Active intraocular inflammation (grade trace or above)
- History of vitreous hemorrhage
- History of rhegmatogenous retinal detachment
- History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
- Aphakia or absence of the posterior capsule
- Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
- Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
- Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
- Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- History of corneal transplant
- History of prior vitrectomy surgery and absence of posterior capsule
- Either Eye
- History of idiopathic or autoimmune-associated uveitis
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- Concurrent Systemic Conditions
- Inability to comply with study schedule or procedures as described in the study protocol
- Uncontrolled blood pressure
- History of stroke within the last 3 months prior to informed consent
- Uncontrolled atrial fibrillation within 3 months of informed consent
- History of myocardial infarction within the last 3 months prior to informed consent
- History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator
- Current systemic treatment for a confirmed active systemic infection
- Use of any systemic anti-VEGF agents
- Chronic use of oral corticosteroids
- Active cancer within 12 months of enrollment
- Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
- Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
- History of albinism
- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
- Sub-study 2
- Concurrent Ocular Conditions-Study Eye
- Any ocular condition that may render the patient at high risk for surgical or treatment complications
- Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
- Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
- History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
- Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
- Ongoing ocular complications that might affect participant safety
- Concurrent Ocular Conditions-Either Eye
- Suspected or active ocular or periocular infection
- Any history of uveitis
- Active blepharitis
- Concurrent Systemic Conditions
- Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
- Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
- Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.
- Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.
Trial locations and contacts
165 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
165 sites in 15 countries
United States81 sites
- Completed
University of New Mexico
Albuquerque, New Mexico, 87131
- Completed
Texas Retina Associates
Arlington, Texas, 76012
- Completed
Southeast Retina Center
Augusta, Georgia, 30909
- Completed
Austin Retina Associates
Austin, Texas, 78705
- Active, not recruiting
Austin Clinical Research LLC
Austin, Texas, 78750
- Completed
California Retina Consultants
Bakersfield, California, 93309
- Completed
The Retina Care Center
Baltimore, Maryland, 21209
- Active, not recruiting
Johns Hopkins Med
Baltimore, Maryland, 21287
- Completed
Retina Consultants of Texas
Bellaire, Texas, 77401
- Completed
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
- Completed
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
- Completed
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
- Completed
Florida Eye Microsurgical Inst
Boynton Beach, Florida, 33426
- Completed
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210
- Completed
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017
- Completed
Retina Group of Washington
Chevy Chase, Maryland, 20815
- Active, not recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
- Completed
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Active, not recruiting
OSU Eye Physicians & Surgeons
Columbus, Ohio, 43212
- Completed
Southwest Retina Consultants
Durango, Colorado, 81303
- Completed
Retina Vitreous Center
Edmond, Oklahoma, 73013
- Active, not recruiting
The Retina Partners
Encino, California, 91436
- Completed
Palmetto Retina Center
Florence, South Carolina, 29501
- Completed
Eye Center of Northern CO
Fort Collins, Colorado, 80528
- Completed
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
- Completed
Texas Retina Associates
Fort Worth, Texas, 76104
- Completed
Charles Retina Institute
Germantown, Tennessee, 38138
- Completed
Foundation for Vision Research
Grand Rapids, Michigan, 49546
- Completed
Long Is. Vitreoretinal Consult
Great Neck, New York, 11021
- Completed
Illinois Retina Associates
Joliet, Illinois, 60435
- Completed
Jacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California, 92037
- Completed
Colorado Retina Associates, PC
Lakewood, Colorado, 80228
- Completed
Retina Associates
Lenexa, Kansas, 66215
- Completed
Retina Associates of Kentucky
Lexington, Kentucky, 40509
- Completed
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095-7000
- Withdrawn
Georgia Retina PC
Marietta, Georgia, 30060
- Completed
Florida Eye Associates
Melbourne, Florida, 32901
- Completed
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, 55435
- Completed
N CA Retina Vitreous Assoc
Mountain View, California, 94040
- Active, not recruiting
Tennessee Retina PC
Nashville, Tennessee, 37203
- Completed
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
- Withdrawn
Paducah Retinal Center
Paducah, Kentucky, 42001
- Completed
Retina Care Specialists
Palm Beach Gardens, Florida, 33410
- Completed
Retina Specialty Institute
Pensacola, Florida, 32503
- Completed
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
- Completed
Retinal Research Institute, LLC
Phoenix, Arizona, 85014
- Completed
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016
- Active, not recruiting
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
- Completed
Associated Retina Consultants
Phoenix, Arizona, 85020
- Completed
Retinal Consultants of Arizona
Phoenix, Arizona, 85053
- Completed
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
- Completed
Maine Eye Center
Portland, Maine, 04101
- Completed
Retina Northwest
Portland, Oregon, 97221
- Completed
Oregon HSU
Portland, Oregon, 97239
- Completed
Retina Consultants, San Diego
Poway, California, 92064
- Active, not recruiting
Sierra Eye Associates
Reno, Nevada, 89502
- Completed
Retina Assoc of Western NY
Rochester, New York, 14620
- Completed
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
- Completed
Associated Retinal Consultants
Royal Oak, Michigan, 48073
- Completed
Retinal Consultants Med Group
Sacramento, California, 95841
- Active, not recruiting
Retina Associates of Utah, PLLC
Salt Lake City, Utah, 84107
- Completed
Rocky Mountain Retina
Salt Lake City, Utah, 84107
- Completed
Med Center Ophthalmology Assoc
San Antonio, Texas, 78240
- Completed
West Coast Retina Medical Group
San Francisco, California, 94109
- Completed
UCSF
San Francisco, California, 94158
- Active, not recruiting
Orange County Retina Med Group
Santa Ana, California, 92705
- Completed
California Retina Consultants
Santa Barbara, California, 93103
- Completed
Pacific Northwest Retina
Silverdale, Washington, 98383
- Completed
Spokane Eye Clinical Research
Spokane, Washington, 99204
- Completed
The Retina Institute - Chesterfield
St Louis, Missouri, 63128
- Active, not recruiting
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711
- Completed
Retina Vit Surgeons/Central NY
Syracuse, New York, 13224
- Active, not recruiting
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308
- Completed
Retina Associates of Florida, LLC
Tampa, Florida, 33609
- Completed
Retina Associates of NJ
Teaneck, New Jersey, 07666
- Completed
Retina Consultants of Texas
The Woodlands, Texas, 77384
- Completed
Retina Specialists
Towson, Maryland, 21204
- Completed
Wagner Kapoor Institute
Virginia Beach, Virginia, 23454
- Completed
Retina Group of New England
Waterford, Connecticut, 06385
- Completed
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169
- Completed
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Italy13 sites, 13 recruiting
- Recruiting
Policlinico di Bari
Bari, Apulia, 70124
- Recruiting
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, 66100
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, 50134
- Recruiting
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy, 20100
- Recruiting
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
- Recruiting
Asst Fatebenefratelli Sacco
Milan, Lombardy, 20157
- Recruiting
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria
Negrar - Verona, Veneto, 37024
- Recruiting
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria, 06129
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
- Recruiting
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, 00198
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches, 60126
- Recruiting
Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore
Trieste, Friuli Venezia Giulia, 34129
- Recruiting
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, 33100
Germany12 sites, 12 recruiting
- Recruiting
Universitatsklinikum Bonn
Bonn, 53127
- Recruiting
Universitatsklinikum Koln
Cologne, 50937
- Recruiting
Medizinische Universitat Lausitz ? Carl Thiem
Cottbus, 03048
- Recruiting
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106
- Recruiting
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
- Recruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
- Recruiting
LMU Klinikum der Universitat, Augenklinik
München, 80336
- Recruiting
Augenabteilung am St. Franziskus-Hospital
Münster, 48145
- Recruiting
Universitatsklinikum Munster
Münster, 48149
- Recruiting
Knappschaftsklinikum Saar GmbH
Sulzbach, 66280
- Recruiting
Universitatsklinikum Tubingen
Tübingen, 72076
- Recruiting
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, 89075
Spain12 sites, 11 recruiting
- Recruiting
Centro de Oftalmologia Barraquer
Barcelona, 08021
- Recruiting
Institut de la Macula i la retina
Barcelona, 08022
- Completed
Hospital dos de maig
Barcelona, 08025
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Oftalvist Valencia
Burjassot, Valencia, 46100
- Recruiting
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, 14012
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Clinica Baviera
Madrid, 28046
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
- Recruiting
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, 33012
- Recruiting
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, 08195
United Kingdom8 sites, 3 recruiting
- Recruiting
Bristol Eye Hospital
Bristol, BS1 2LX
- Active, not recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
- Active, not recruiting
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
- Recruiting
Central Middlesex Hospital
London, NW10 7NS
- Active, not recruiting
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
- Active, not recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
- Active, not recruiting
Sunderland Eye Infirmary
Sunderland, SR2 9HP
- Recruiting
Royal Wolverhampton hospital
Wolverhampton, WV10 0QP
Israel6 sites, 6 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109601
- Recruiting
Hadassah MC
Jerusalem, 9112001
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
- Recruiting
Rabin MC
Petah Tikva, 4941492
- Recruiting
Kaplan Medical Center
Rehovot, 7660101
- Recruiting
Tel Aviv Sourasky MC
Tel Aviv, 6423906
Brazil5 sites, 5 recruiting
- Recruiting
Botelho Hospital da Visao
Blumenau, Santa Catarina, 89052-504
- Recruiting
Retina Clinic
São Paulo, São Paulo, 01427-002
- Recruiting
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, 04023-062
- Recruiting
Instituto da Visao IPEPO
São Paulo, São Paulo, 04038-032
- Recruiting
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, 18031-060
France5 sites, 5 recruiting
- Recruiting
Centre Retine Gallien
Bordeaux, 33000
- Recruiting
Hopital de la croix rousse
Lyon, 69317
- Recruiting
Centre Paradis Monticelli
Marseille, 13008
- Recruiting
Hopital Lariboisiere
Paris, 75010
- Recruiting
Fondation Rothschild
Paris, 75940
Switzerland5 sites, 3 recruiting
- Recruiting
Universitatsspital Basel Augenklinik Klinik
Basel, 4056
- Recruiting
Inselspital Universitaetsklinik fuer Augenheilkunde;Marie-Colinet-Haus
Bern, 3010
- Active, not recruiting
Vista Klinik Ophthalmologische Klinik
Binningen, 4102
- Recruiting
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
Lausanne
- Active, not recruiting
Stadtspital Triemli Ophthalmologische Klinik
Zurich, 8063
Taiwan5 sites, 5 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 500
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
- Recruiting
National Taiwan University Hospital
Zhongzheng Dist., 10002
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Hacettepe University Medical Faculty
Ankara, 06100
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06490
- Recruiting
Ankara Etlik City Hospital
Ankara, DUMMY_VALUE
- Recruiting
Beyoglu Goz Training and Research Hospital
Istanbul, 34421
- Recruiting
Kocaeli University Medical Faculty
Kocaeli, 41380
Argentina3 sites, 2 recruiting
- Recruiting
Oftalmos
Capital Federal, C1120AAN
- Recruiting
Centro Oftalmologico Dr. Charles S.A.
Ciudad Autonoma Buenos Aires, C1121ABB
- Active, not recruiting
Grupo Laser Vision
Rosario, S2000DLA
Australia2 sites, 1 recruiting
- Active, not recruiting
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640
- Recruiting
Eye and Retina Consultants
Hurstville, New South Wales, 2220
Austria2 sites, 2 recruiting
- Recruiting
LKH-Univ.Klinikum Graz
Graz, 8036
- Recruiting
Medizinische Universitat Wien
Vienna, 1090
About this study
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)
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.
Read the 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.
- Being tested
- PDS Implant with Ranibizumab 100 mg/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS Implant with Ranibizumab 100 mg/mLDrug
Will be administered as per the schedule described in individual arm
| Study group | Role | What they receive |
|---|---|---|
| PDS Implant Cohort 1 (US only) | Experimental | Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.
Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 2 (US only) | Experimental | Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.
Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 3 (US only) | Experimental | Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.
Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 4 (US only) | Experimental | Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.
Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 5 (ex-US only) | Experimental | Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 6 (ex-US only) | Experimental | Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| PDS Implant Cohort 7 (ex-US only) | Experimental | Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| Sub-study 1: PDS Implant | Experimental | Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| Sub-study 2: Cohort 1 | Experimental | Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| Sub-study 2: Cohort 2a | Experimental | Participants who received an updated PDS implant, have < 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
| Sub-study 2: Cohort 2b | Experimental | Participants who received an updated PDS implant, have < 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. Receives: Drug: PDS Implant with Ranibizumab 100 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Measured: Baseline up to Week 240
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Measured: Baseline up to Week 240
Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study
Measured: Baseline up to Week 240
Incidence and Severity of Adverse Device Effects
Measured: Baseline up to Week 240
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
Measured: Baseline up to Week 240
Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery.
Measured: Baseline to Week 4
Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs
Measured: Baseline to Week 72
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs
Measured: Baseline to Week 72
Sub-study 2: Duration of AESIs
Measured: Baseline to Week 72
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period
Measured: Up to Day 37 post re-implantation
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period
Measured: > 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period
Measured: Up to Day 37 post re-implantation
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period
Measured: > 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs
Measured: Baseline to Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs
Measured: Baseline to Week 72
Sub-study 2: Duration of Anticipated Serious ADEs
Measured: Baseline to Week 72
Sub-study 2: Number of Device Deficiencies
Measured: Baseline to Week 72
Secondary outcomes (21)
Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
ETDRS = Early Treatment Diabetic Retinopathy Study
A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Measured: Baseline up to Week 240
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Measured: Baseline up to Week 240
Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time
Measured: Baseline up to Week 240
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Measured: Baseline up to Week 240
Change from Baseline in Center Point Thickness (CPT) Over Time
CPT is defined as the retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT is measured using optical coherence tomography (OCT).
Measured: Baseline up to Week 240
Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg During Each Refill-exchange Interval
Measured: Baseline up to Week 240
Sub-study 1: Incidence of Ocular Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) in the Study eye
Measured: Baseline up to Week 104
Sub-study 1: Incidence of AEs Commonly Seen After Transscleral Cyclophotocoagulation (TS-CPC) for Treatment of Glaucoma in the Study eye
Measured: Baseline up to Week 104
Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye
Measured: Baseline up to Week 104
Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time
Measured: Baseline up to Week 104
Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time
Measured: Baseline up to Week 104
Sub-study 1: Rate of Vitrectomy in the Study eye
Measured: Baseline up to Week 104
Sub-study 1: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score From Baseline Over Time
Measured: Baseline up to Week 104
Sub-study 1: Change in BCVA Score From Baseline Over Time
Measured: Baseline up to Week 104
Sub-study 1: Change from Baseline in CPT Over Time
Measured: Baseline up to Week 104
Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time
Measured: Baseline up to Week 104
Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange
Measured: Up to approximately Week 72
Sub-study 2: Duration of AESIs Following Refill-exchange
Measured: Up to approximately Week 72
Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange
Measured: Up to approximately Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs Following Refill-exchange
Measured: Up to approximately Week 72
Sub-study 2: Number of Device Deficiencies Following Refill-exchange
Measured: Up to approximately Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start20 Sep 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683251
- Sponsor's protocol ID
- GR40549
- Other IDs
- 2020-004427-16, 2023-507131-38-00, 2023
- Acronym
- Portal
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2018
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Campochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30.
PubMed 39209113Eichenbaum DA, Freeman WR, Chang MA, Brooks L, Chaudhry N, Dadgostar H, McCannel CA, Michels M, Mittra RA, Wolfe JD, Beindl VC, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development. Ophthalmol Retina. 2025 Feb;9(2):127-143. doi: 10.1016/j.oret.2024.08.005. Epub 2024 Aug 16.
PubMed 39154860