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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)

Primary Purpose

Neovascular Age-related Macular Degeneration (nAMD)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ranibizumab
Port Delivery System with Ranibizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 6 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
  • 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 rhegmatogenous 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

Sites / Locations

  • Centro Oftalmológico Dr. Charles S.A.Recruiting
  • OftalmosRecruiting
  • Grupo Laser VisionRecruiting
  • Eyeclinic Albury WodongaRecruiting
  • Eye and Retina ConsultantsRecruiting
  • Retina and Macula SpecialistsRecruiting
  • Retina Associates LiverpoolRecruiting
  • Sydney Eye HospitalRecruiting
  • Sydney Retina Clinic and Day SurgeryRecruiting
  • Queensland Eye InstituteRecruiting
  • Centre For Eye Research AustraliaRecruiting
  • Retina Specialists VictoriaRecruiting
  • The Lions Eye InstituteRecruiting
  • LKH-Univ.Klinikum Graz; Universitäts-AugenklinikRecruiting
  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und OptometrieRecruiting
  • CHU Brugmann (Victor Horta)Recruiting
  • UZ GentRecruiting
  • UZ Leuven GasthuisbergRecruiting
  • Botelho Hospital da Visao
  • Retina ClinicRecruiting
  • Universidade Federal de Sao Paulo - UNIFESP*X; OftalmologiaRecruiting
  • Instituto da Visão IPEPORecruiting
  • Hosp de Olhos de SorocabaRecruiting
  • Chi De Creteil; Ophtalmologie
  • Hopital de la croix rousse; OphtalmologieRecruiting
  • Fondation Rothschild; OphtalmologieRecruiting
  • Hopital Lariboisiere; OphtalmologieRecruiting
  • Städtisches Klinikum Dresden; Augenklinik
  • Universitätsklinikum Freiburg, Klinik für AugenheilkundeRecruiting
  • Universitätsklinikum Köln; AugenklinikRecruiting
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; AugenklinikRecruiting
  • LMU Klinikum der Universität, AugenklinikRecruiting
  • Universitätsklinikum Münster; AugenheilkundeRecruiting
  • Universitätsklinikum Regensburg, Klinik & Poliklinik für AugenheilkundeRecruiting
  • Knappschaftsklinikum Saar GmbH; Augenklinik SulzbachRecruiting
  • Universitätsklinikum TübingenRecruiting
  • Universitätsklinikum Ulm, Augenklinik und PoliklinikRecruiting
  • Rambam Medical Center; OpthalmologyRecruiting
  • Hadassah MC; OphtalmologyRecruiting
  • Meir Medical Center; OphtalmologyRecruiting
  • Rabin MC; OphtalmologyRecruiting
  • Kaplan Medical Center; OphtalmologyRecruiting
  • Tel Aviv Sourasky MC; OphtalmologyRecruiting
  • Ospedale Clinicizzato SS Annunziata; Clinica OftalmologicaRecruiting
  • Policlinico Tor VergataRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C OculisticaRecruiting
  • Irccs Ospedale San Raffaele;U.O. OculisticaRecruiting
  • Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento OculisticaRecruiting
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica OculisticaRecruiting
  • Pusan National University HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Kyung Hee University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • National University Hospital; Ophthalmology Department
  • Singapore Eye Research Institute
  • Eye & Retina SurgeonsRecruiting
  • Tan Tock Seng Hospital; Ophthalmology Department
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital General de CatalunyaRecruiting
  • Hospital Universitario Puerta de HierroRecruiting
  • Clinica Universitaria de Navarra; Servicio de OftalmologiaRecruiting
  • Oftalvist ValenciaRecruiting
  • Centro de Oftalmologia Barraquer; Servicio OftalmologiaRecruiting
  • Institut de la Macula i la retinaRecruiting
  • Hospital dos de maig; servicio de oftalmologiaRecruiting
  • Hospital Clinic de Barcelona; Consultas Externas OftalmologiaRecruiting
  • Clinica Universitaria de Navarra; Servicio de OftalmologiaRecruiting
  • Clinica Baviera; Servicio OftalmologiaRecruiting
  • Hospital Universitario Rio Hortega; Servicio de OftalmologiaRecruiting
  • Universitätsspital Basel Augenklinik KlinikRecruiting
  • Inselspital Bern Ophthalmologische KlinikRecruiting
  • Vista Klinik Ophthalmologische Klinik
  • Fondation Asile Des Aveugles ? Jules Gonin Eye HospitalRecruiting
  • Stadtspital Triemli Ophthalmologische Klinik
  • Changhua Christian Hospital; Department of OphthalmologyRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital; OphthalmologyRecruiting
  • Taipei Veterans General Hospital; OphthalmologyRecruiting
  • Chang Gung Medical Foundation - Linkou; Ophthalmology
  • National Taiwan University Hospital; OphthalmologyRecruiting
  • Ankara Ulucanlar Eye Research and Application Hospital; Ophthalmology
  • Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
  • Bristol Eye Hospital;Retinal Treatment and Research UnitRecruiting
  • Hull University Teaching Hospitals NHS TrustRecruiting
  • Royal Liverpool University HospitalRecruiting
  • Moorfields Eye Hospital NHS Foundation Trust
  • Kings College HospitalRecruiting
  • Manchester University NHS Foundation Trust (MFT)
  • Royal Victoria InfirmaryRecruiting
  • Sunderland Eye InfirmaryRecruiting
  • New Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A [Q36W] 36-weeks between refill-exchange procedures

Arm B [Q24W] 24-weeks between refill-exchange procedures

Arm Description

Participants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.

Participants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in BCVA score over time
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time
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
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
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
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time
Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms
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
Incidence and severity of adverse device effects in the Q36W and Q24W arms
Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms
Change from baseline in center point thickness (CPT) up to and including Week 72
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Observed serum concentration of ranibizumab at specified timepoints
Incidence of treatment-emergent ADAs during the study

Full Information

First Posted
December 1, 2020
Last Updated
September 25, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04657289
Brief Title
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)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration (nAMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3b
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
442 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A [Q36W] 36-weeks between refill-exchange procedures
Arm Type
Experimental
Arm Description
Participants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.
Arm Title
Arm B [Q24W] 24-weeks between refill-exchange procedures
Arm Type
Active Comparator
Arm Description
Participants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Port Delivery System with Ranibizumab
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 72
Secondary Outcome Measure Information:
Title
Change from baseline in BCVA score over time
Time Frame
Baseline up to Week 72
Title
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72
Time Frame
Baseline to Week 72
Title
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time
Time Frame
Baseline up to Week 72
Title
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72
Time Frame
Baseline to Week 72
Title
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time
Time Frame
Baseline up to Week 72
Title
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
Time Frame
At Weeks 24, 40, 72
Title
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
Time Frame
At Weeks 24, 40, 72
Title
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
Time Frame
At Week 40
Title
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72
Time Frame
Baseline to Week 72
Title
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time
Time Frame
Baseline up to Week 72
Title
Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms
Time Frame
Baseline up to Week 72
Title
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms
Time Frame
Baseline up to Week 72
Title
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
Time Frame
Baseline up to Week 72
Title
Incidence and severity of adverse device effects in the Q36W and Q24W arms
Time Frame
Baseline up to Week 72
Title
Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms
Time Frame
Baseline up to Week 72
Title
Change from baseline in center point thickness (CPT) up to and including Week 72
Time Frame
Baseline up to Week 72
Title
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Time Frame
Week 16 to Week 68
Title
Observed serum concentration of ranibizumab at specified timepoints
Time Frame
Baseline to Week 72
Title
Incidence of treatment-emergent ADAs during the study
Time Frame
Baseline to Week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 6 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 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 rhegmatogenous 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WR42221 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Centro Oftalmológico Dr. Charles S.A.
City
Capital Federal
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Grupo Laser Vision
City
Rosario
ZIP/Postal Code
S2000DLA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Eyeclinic Albury Wodonga
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Eye and Retina Consultants
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Retina and Macula Specialists
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Retina Associates Liverpool
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Retina Clinic and Day Surgery
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Queensland Eye Institute
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Centre For Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Retina Specialists Victoria
City
Rowville
State/Province
Victoria
ZIP/Postal Code
3178
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
CHU Brugmann (Victor Horta)
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Botelho Hospital da Visao
City
Blumenau
State/Province
SC
ZIP/Postal Code
89052-504
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Retina Clinic
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01427-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto da Visão IPEPO
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-032
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hosp de Olhos de Sorocaba
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18031-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Chi De Creteil; Ophtalmologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Suspended
Facility Name
Hopital de la croix rousse; Ophtalmologie
City
Lyon cedex
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Name
Fondation Rothschild; Ophtalmologie
City
Paris Cedex 19
ZIP/Postal Code
75940
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lariboisiere; Ophtalmologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Städtisches Klinikum Dresden; Augenklinik
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Köln; Augenklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Name
LMU Klinikum der Universität, Augenklinik
City
München
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster; Augenheilkunde
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach
City
Sulzbach
ZIP/Postal Code
66280
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm, Augenklinik und Poliklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Opthalmology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah MC; Ophtalmology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center; Ophtalmology
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin MC; Ophtalmology
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center; Ophtalmology
City
Rehovot
ZIP/Postal Code
7660101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky MC; Ophtalmology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Ospedale San Raffaele;U.O. Oculistica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica
City
Negrar - Verona
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
City
Udine
State/Province
Veneto
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National University Hospital; Ophthalmology Department
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Eye & Retina Surgeons
City
Singapore
ZIP/Postal Code
248649
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital; Ophthalmology Department
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Catalunya
City
San Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Oftalvist Valencia
City
Burjassot
State/Province
Valencia
ZIP/Postal Code
46100
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro de Oftalmologia Barraquer; Servicio Oftalmologia
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut de la Macula i la retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital dos de maig; servicio de oftalmologia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Baviera; Servicio Oftalmologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitätsspital Basel Augenklinik Klinik
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Inselspital Bern Ophthalmologische Klinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Vista Klinik Ophthalmologische Klinik
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
City
Lausanne
ZIP/Postal Code
1002
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Stadtspital Triemli Ophthalmologische Klinik
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Changhua Christian Hospital; Department of Ophthalmology
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital; Ophthalmology
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital; Ophthalmology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Linkou; Ophthalmology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Taiwan University Hospital; Ophthalmology
City
Zhongzheng Dist.
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Ankara Ulucanlar Eye Research and Application Hospital; Ophthalmology
City
Ankara
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Bristol Eye Hospital;Retinal Treatment and Research Unit
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Manchester University NHS Foundation Trust (MFT)
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sunderland Eye Infirmary
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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)

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