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NCT04657289

PHASE3

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)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

451

Start Date

2021-07-14

Completion Date

2027-01-07

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Interventions

DRUG

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

DEVICE

Port Delivery System with Ranibizumab

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Locations (108)

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 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

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)