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AzTrials

Neovascular Age-related Macular Degeneration (nAMD)Phase 3NCT04657289

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 3 study testing Ranibizumab and Port Delivery System with Ranibizumab in people with Neovascular Age-related Macular Degeneration (nAMD), run by Hoffmann-La Roche at 104 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ranibizumab and Port Delivery System with Ranibizumab
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
104 sitesin 16 countries
Study dates
14 Jul 2021to 4 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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

Trial locations and contacts

104 sites in 16 countries.

104 sites in 16 countries

Italy13 sites

  • Policlinico di Bari

    Bari, Apulia, 70124

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

    Milan, Lombardy, 20100

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Asst Fatebenefratelli Sacco

    Milan, Lombardy, 20157

  • Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria

    Negrar - Verona, Veneto, 37024

  • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

    Perugia, Umbria, 06129

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Rome, Lazio, 00198

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette - Ancona, The Marches, 60126

  • Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore

    Trieste, Friuli Venezia Giulia, 34129

  • A.O. Universitaria S. Maria Della Misericordia Di Udine

    Udine, Veneto, 33100

Other trials in Italy

Germany12 sites

  • Universitatsklinikum Bonn

    Bonn, 53127

  • Universitatsklinikum Koln

    Cologne, 50937

  • Medizinische Universitat Lausitz ? Carl Thiem

    Cottbus, 03048

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • LMU Klinikum der Universitat, Augenklinik

    München, 80336

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145

  • Universitatsklinikum Munster

    Münster, 48149

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280

  • Universitatsklinikum Tubingen

    Tübingen, 72076

  • Universitatsklinikum Ulm, Augenklinik und Poliklinik

    Ulm, 89075

Other trials in Germany

Spain12 sites

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021

  • Institut de la Macula i la retina

    Barcelona, 08022

  • Hospital dos de maig

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Clinica Baviera

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Instituto Oftalmologico Fernandez Vega

    Oviedo, Principality of Asturias, 33012

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

  • Oftalvist Valencia

    Valencia, 46004

Other trials in Spain

Australia10 sites

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • Eye and Retina Consultants

    Hurstville, New South Wales, 2220

  • Retina Associates Liverpool

    Liverpool, New South Wales, 2170

  • Retina and Macula Specialists

    Miranda, New South Wales, 2228

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Retina Specialists Victoria

    Rowville, Victoria, 3178

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

  • Queensland Eye Institute

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea8 sites

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Medical Center

    Daegu, 42415

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

United Kingdom8 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • Central Middlesex Hospital

    London, NW10 7NS

  • Kings College Hospital

    London, SE5 9RS

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Brazil6 sites

  • Botelho Hospital da Visao

    Blumenau, Santa Catarina, 89052-504

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul

  • Retina Clinic

    São Paulo, São Paulo, 01427-002

  • Universidade Federal de Sao Paulo - UNIFESPX

    São Paulo, São Paulo, 04023-062

  • Instituto da Visao IPEPO

    São Paulo, São Paulo, 04038-032

  • Hosp de Olhos de Sorocaba

    Sorocaba, São Paulo, 18031-060

Other trials in Brazil

Israel6 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah MC

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin MC

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7660101

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906

Other trials in Israel

France5 sites

  • Centre Retine Gallien

    Bordeaux, 33000

  • Hopital de la croix rousse

    Lyon, 69317

  • Centre Paradis Monticelli

    Marseille, 13008

  • Hopital Lariboisiere

    Paris, 75010

  • Fondation Rothschild

    Paris, 75940

Other trials in France

Switzerland5 sites

  • Universitatsspital Basel Augenklinik Klinik

    Basel, 4056

  • Inselspital Bern Ophthalmologische Klinik

    Bern, 3010

  • Vista Klinik Ophthalmologische Klinik

    Binningen, 4102

  • Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital

    Lausanne

  • Stadtspital Triemli Ophthalmologische Klinik

    Zurich, 8063

Other trials in Switzerland

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Ankara Bilkent City Hospital

    Ankara, 06490

  • Ankara Etlik City Hospital

    Ankara

  • Beyoglu Goz Training and Research Hospital

    Istanbul, 34421

  • Kocaeli Universitesi T?p Fakultesi

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1116

  • Oftalmos

    Capital Federal, C1120AAN

  • Grupo Laser Vision

    Rosario, S2000DLA

Other trials in Argentina

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore Eye Research Institute

    Singapore, 168751

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Austria2 sites

  • LKH-Univ.Klinikum Graz

    Graz, 8036

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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)

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).

Being tested
Ranibizumab, Port Delivery System with Ranibizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanibizumabDrug

    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 RanibizumabDevice

    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

Study groups in NCT04657289
Study groupRoleWhat they receive
Arm A [Q36W] 36-weeks between refill-exchange proceduresExperimentalParticipants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.
Receives: Drug: Ranibizumab; Device: Port Delivery System with Ranibizumab
Arm B [Q24W] 24-weeks between refill-exchange proceduresActive comparatorParticipants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.
Receives: Drug: Ranibizumab; Device: Port Delivery System with Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 72

Secondary outcomes (19)

  1. Change from baseline in BCVA score over time

    Measured: Baseline up to Week 72

  2. Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72

    Measured: Baseline to Week 72

  3. Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time

    Measured: Baseline up to Week 72

  4. Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72

    Measured: Baseline to Week 72

  5. Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time

    Measured: Baseline up to Week 72

  6. Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at At Weeks 24, 40 and 72

    Measured: At Weeks 24, 40, 72

  7. Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at At Weeks 24, 40 and 72

    Measured: At Weeks 24, 40, 72

  8. Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm

    Measured: At Week 40

  9. Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72

    Measured: Baseline to Week 72

  10. Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time

    Measured: Baseline up to Week 72

  11. Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms

    Measured: Baseline up to Week 72

  12. Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms

    Measured: Baseline up to Week 72

  13. Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 days of initial implantation) and follow-up period (> 37 days after implantation surgery) in all enrolled participants

    Measured: Baseline up to Week 72

  14. Incidence and severity of adverse device effects in the Q36W and Q24W arms

    Measured: Baseline up to Week 72

  15. Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms

    Measured: Baseline up to Week 72

  16. Change from baseline in center point thickness (CPT) up to and including Week 72

    Measured: Baseline up to Week 72

  17. Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure

    Measured: Week 16 to Week 68

  18. Observed serum concentration of ranibizumab at specified timepoints

    Measured: Baseline to Week 72

  19. Incidence of treatment-emergent ADAs during the study

    Measured: Baseline to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start14 Jul 2021
  3. Primary completion4 Feb 2027 (estimated)
  4. Study completion4 Feb 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Phase 3b
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657289
Sponsor's protocol ID
WR42221
Other IDs
2020-001313-20, CIV-21-02-035827, 2023-507130-24-00, 2023
Status last verified
Oct 2026
First submitted
1 Dec 2020
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab and Port Delivery System with Ranibizumab in people with Neovascular Age-related Macular Degeneration (nAMD), run by Hoffmann-La Roche at 104 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in Italy, Germany, Spain, Australia, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline to Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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