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)
A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked 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)
4 other identifiers
interventional
451
15 countries
102
Brief Summary
Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2021
Longer than P75 for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2027
May 5, 2026
May 1, 2026
5.5 years
December 1, 2020
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters
EDTRS = 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.
Baseline to Week 72
Secondary Outcomes (19)
Change from baseline in BCVA score over time
Baseline up to Week 72
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72
Baseline to Week 72
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time
Baseline up to Week 72
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72
Baseline to Week 72
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time
Baseline up to Week 72
- +14 more secondary outcomes
Study Arms (2)
Arm A [Q36W] 36-weeks between refill-exchange procedures
EXPERIMENTALParticipants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.
Arm B [Q24W] 24-weeks between refill-exchange procedures
ACTIVE COMPARATORParticipants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.
Interventions
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 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
You may qualify if:
- Age ≥ 50 years at time of signing Informed Consent Form
- 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
You may not qualify if:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1116, Argentina
Oftalmos
Capital Federal, C1120AAN, 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
Retina Associates Liverpool
Liverpool, New South Wales, 2170, Australia
Retina and Macula Specialists
Miranda, New South Wales, 2228, Australia
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Queensland Eye Institute
Woolloongabba, Queensland, 4102, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Retina Specialists Victoria
Rowville, Victoria, 3178, Australia
The Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
LKH-Univ.Klinikum Graz
Graz, 8036, Austria
Medizinische Universitat Wien
Vienna, 1090, Austria
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
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
National University Hospital
Singapore, 119074, Singapore
Singapore Eye Research Institute
Singapore, 168751, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
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
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
Oftalvist Valencia
Valencia, 46004, 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, Turkey (Türkiye)
Beyoglu Goz Training and Research Hospital
Istanbul, 34421, Turkey (Türkiye)
Kocaeli Universitesi T?p Fakultesi
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
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- * The BCVA examiner will only conduct refraction and BCVA assessments and will be masked to participant study eye assignment and study visit type. * 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 8, 2020
Study Start
July 14, 2021
Primary Completion (Estimated)
January 28, 2027
Study Completion (Estimated)
January 28, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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