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)
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
Study 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).
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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 — Baseline to Week 72 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.
Trial sites (104)
Facility
City
Region
Status
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
Eye and Retina Consultants
Hurstville
New South Wales
Retina Associates Liverpool
Liverpool
New South Wales
Retina and Macula Specialists
Miranda
New South Wales
Sydney Eye Hospital
Sydney
New South Wales
Sydney Retina Clinic and Day Surgery
Sydney
New South Wales
Queensland Eye Institute
Woolloongabba
Queensland
Centre For Eye Research Australia
East Melbourne
Victoria
Retina Specialists Victoria
Rowville
Victoria
The Lions Eye Institute
Nedlands
Western 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
Botelho Hospital da Visao
Blumenau
Santa Catarina
Retina Clinic
São Paulo
São Paulo
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo
São Paulo
Instituto da Visao IPEPO
São Paulo
São Paulo
Hosp de Olhos de Sorocaba
Sorocaba
São Paulo
Centre Retine Gallien
Bordeaux
France
Hopital de la croix rousse
Lyon
France
Centre Paradis Monticelli
Marseille
France
Hopital Lariboisiere
Paris
France
Fondation Rothschild
Paris
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
+ 64 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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