A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)
NCT ID: NCT04657289
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
451 participants
INTERVENTIONAL
2021-07-14
2027-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
* The BCVA examiner will have no access to a participant's BCVA scores from previous visits and will be aware only of the participant's refraction data from previous visits.
* The BCVA examiner may provide no other direct or indirect participant care.
Study Groups
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Arm A [Q36W] 36-weeks between refill-exchange procedures
Participants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.
Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Port Delivery System with Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Arm B [Q24W] 24-weeks between refill-exchange procedures
Participants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.
Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Port Delivery System with Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Interventions
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Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Port Delivery System with Ranibizumab
Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Eligibility Criteria
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Inclusion Criteria
* Initial diagnosis of nAMD within 9 months prior to the screening visit
* Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
* Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
* Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
* BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better
Exclusion Criteria
* Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
* Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eye
* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eye
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
* Prior treatment with brolucizumab (at any time prior to the screening visit) in either eye
* Prior participation in a clinical trial involving any anti-VEGF drugs, within 9 months prior to the enrollment visit in either eye
* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is \>0.5 disc area at screening in study eye
* Subfoveal fibrosis or subfoveal atrophy in study eye
* Choroidal neovascularization (CNV) due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eye
* Retinal pigment epithelial tear in study eye
* Any concurrent intraocular condition 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 in study eye
* Active intraocular inflammation in study eye
* History of vitreous hemorrhage in study eye
* History of rhegmatogenous retinal detachment in study eye
* History of retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eye
* History of pars plana vitrectomy surgery
* Aphakia or absence of the posterior capsule in study eye
* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eye
* Preoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eye
* Intraocular surgery within 3 months preceding the enrollment visit in study eye
* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study in study eye
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eye
* History of corneal transplant in study eye
* Any history of uveitis requiring treatment in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled blood pressure
* History of stroke within the last 3 months prior to informed consent
* Atrial fibrillation diagnosed or worsened within the last 3 months prior to 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 participant at high risk of treatment complications in the opinion of the investigator
* Confirmed active systemic infection
* Use of any systemic anti-VEGF agents
* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \<= 6 and a stable prostate-specific antigen for \> 12 months
* Previous participation in any non-ocular disease studies of investigational drugs within 1 month preceding the informed consent
* Non-functioning non-study eye
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Centro Oftalmologico Dr. Charles S.A.
Capital Federal, , Argentina
Oftalmos
Capital Federal, , Argentina
Grupo Laser Vision
Rosario, , Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Eye and Retina Consultants
Hurstville, New South Wales, Australia
Retina Associates Liverpool
Liverpool, New South Wales, Australia
Retina and Macula Specialists
Miranda, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Queensland Eye Institute
Woolloongabba, Queensland, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
LKH-Univ.Klinikum Graz
Graz, , Austria
Medizinische Universitat Wien
Vienna, , Austria
UZ Leuven Gasthuisberg
Leuven, , Belgium
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Botelho Hospital da Visao
Blumenau, Santa Catarina, Brazil
Retina Clinic
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, Brazil
Instituto da Visao IPEPO
São Paulo, São Paulo, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, Brazil
Centre Retine Gallien
Bordeaux, , France
Hopital de la croix rousse
Lyon, , France
Centre Paradis Monticelli
Marseille, , France
CHU Nantes - Hotel Dieu
Nantes, , France
Hopital Lariboisiere
Paris, , France
Fondation Rothschild
Paris, , France
Hopital PURPAN - CHU TOULOUSE
Toulouse, , France
Universitatsklinikum Bonn
Bonn, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Medizinische Universitat Lausitz ? Carl Thiem
Cottbus, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
LMU Klinikum der Universitat, Augenklinik
München, , Germany
Augenabteilung am St. Franziskus-Hospital
Münster, , Germany
Universitatsklinikum Munster
Münster, , Germany
Knappschaftsklinikum Saar GmbH
Sulzbach, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, , Germany
Rambam Medical Center
Haifa, , Israel
Hadassah MC
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin MC
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky MC
Tel Aviv, , Israel
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, Italy
Policlinico di Bari
Bari, Apulia, Italy
Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore
Trieste, Friuli Venezia Giulia, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Fatebenefratelli Sacco
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria, Italy
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria
Negrar - Verona, Veneto, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, Italy
National University Hospital
Singapore, , Singapore
Singapore Eye Research Institute
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, Spain
Centro de Oftalmologia Barraquer
Barcelona, , Spain
Institut de la Macula i la retina
Barcelona, , Spain
Hospital dos de maig
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, , Spain
Clinica Universitaria de Navarra
Madrid, , Spain
Clinica Baviera
Madrid, , Spain
Oftalvist Valencia
Valencia, , Spain
Universitatsspital Basel Augenklinik Klinik
Basel, , Switzerland
Inselspital Bern Ophthalmologische Klinik
Bern, , Switzerland
Vista Klinik Ophthalmologische Klinik
Binningen, , Switzerland
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
Lausanne, , Switzerland
Stadtspital Triemli Ophthalmologische Klinik
Zurich, , Switzerland
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
National Taiwan University Hospital
Zhongzheng Dist., , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Beyoglu Goz Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Kocaeli Universitesi T?p Fakultesi
Kocaeli, , Turkey (Türkiye)
Bristol Eye Hospital
Bristol, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Central Middlesex Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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2020-001313-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CIV-21-02-035827
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507130-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
WR42221
Identifier Type: -
Identifier Source: org_study_id