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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04657289




Registration number
NCT04657289
Ethics application status
Date submitted
1/12/2020
Date registered
8/12/2020
Date last updated
26/06/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2020-001313-20
Secondary ID [2] 0 0
WR42221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration (nAMD) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Treatment: Devices - Port Delivery System with Ranibizumab

Experimental: Arm A [Q36W] 36-weeks between refill-exchange procedures - Participants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval.

Active comparator: Arm B [Q24W] 24-weeks between refill-exchange procedures - Participants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval.


Treatment: Drugs: 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

Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Week 72
Secondary outcome [1] 0 0
Change from baseline in BCVA score over time
Timepoint [1] 0 0
Baseline up to Week 72
Secondary outcome [2] 0 0
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72
Timepoint [2] 0 0
Baseline to Week 72
Secondary outcome [3] 0 0
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time
Timepoint [3] 0 0
Baseline up to Week 72
Secondary outcome [4] 0 0
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72
Timepoint [4] 0 0
Baseline to Week 72
Secondary outcome [5] 0 0
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time
Timepoint [5] 0 0
Baseline up to Week 72
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
At Weeks 24, 40, 72
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
At Weeks 24, 40, 72
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
At Week 40
Secondary outcome [9] 0 0
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72
Timepoint [9] 0 0
Baseline to Week 72
Secondary outcome [10] 0 0
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time
Timepoint [10] 0 0
Baseline up to Week 72
Secondary outcome [11] 0 0
Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms
Timepoint [11] 0 0
Baseline up to Week 72
Secondary outcome [12] 0 0
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms
Timepoint [12] 0 0
Baseline up to Week 72
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline up to Week 72
Secondary outcome [14] 0 0
Incidence and severity of adverse device effects in the Q36W and Q24W arms
Timepoint [14] 0 0
Baseline up to Week 72
Secondary outcome [15] 0 0
Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms
Timepoint [15] 0 0
Baseline up to Week 72
Secondary outcome [16] 0 0
Change from baseline in center point thickness (CPT) up to and including Week 72
Timepoint [16] 0 0
Baseline up to Week 72
Secondary outcome [17] 0 0
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Timepoint [17] 0 0
Week 16 to Week 68
Secondary outcome [18] 0 0
Observed serum concentration of ranibizumab at specified timepoints
Timepoint [18] 0 0
Baseline to Week 72
Secondary outcome [19] 0 0
Incidence of treatment-emergent ADAs during the study
Timepoint [19] 0 0
Baseline to Week 72

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
442
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Eye and Retina Consultants - Hurstville
Recruitment hospital [3] 0 0
Retina and Macula Specialists - Hurstville
Recruitment hospital [4] 0 0
Retina Associates Liverpool - Liverpool
Recruitment hospital [5] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [6] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [7] 0 0
Queensland Eye Institute - Woolloongabba
Recruitment hospital [8] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [9] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [10] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3178 - Rowville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Capital Federal
Country [2] 0 0
Argentina
State/province [2] 0 0
Rosario
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Brazil
State/province [8] 0 0
GO
Country [9] 0 0
Brazil
State/province [9] 0 0
MG
Country [10] 0 0
Brazil
State/province [10] 0 0
RJ
Country [11] 0 0
Brazil
State/province [11] 0 0
SC
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Creteil
Country [15] 0 0
France
State/province [15] 0 0
Lyon cedex
Country [16] 0 0
France
State/province [16] 0 0
Paris Cedex 19
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Germany
State/province [19] 0 0
Freiburg
Country [20] 0 0
Germany
State/province [20] 0 0
Köln
Country [21] 0 0
Germany
State/province [21] 0 0
Ludwigshafen
Country [22] 0 0
Germany
State/province [22] 0 0
München
Country [23] 0 0
Germany
State/province [23] 0 0
Münster
Country [24] 0 0
Germany
State/province [24] 0 0
Regensburg
Country [25] 0 0
Germany
State/province [25] 0 0
Sulzbach
Country [26] 0 0
Germany
State/province [26] 0 0
Tübingen
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
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Israel
State/province [29] 0 0
Jerusalem
Country [30] 0 0
Israel
State/province [30] 0 0
Kfar Saba
Country [31] 0 0
Israel
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Petach Tikva
Country [32] 0 0
Israel
State/province [32] 0 0
Rehovot
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Italy
State/province [34] 0 0
Abruzzo
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Veneto
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Korea, Republic of
State/province [38] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Valencia
Country [48] 0 0
Spain
State/province [48] 0 0
Valladolid
Country [49] 0 0
Switzerland
State/province [49] 0 0
Basel
Country [50] 0 0
Switzerland
State/province [50] 0 0
Bern
Country [51] 0 0
Switzerland
State/province [51] 0 0
Binningen
Country [52] 0 0
Switzerland
State/province [52] 0 0
Lausanne
Country [53] 0 0
Switzerland
State/province [53] 0 0
Zürich
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Taiwan
State/province [54] 0 0
Changhua
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Taiwan
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Kaohsiung
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Taiwan
State/province [56] 0 0
Taipei
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taoyuan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Zhongzheng Dist.
Country [59] 0 0
Turkey
State/province [59] 0 0
Ankara
Country [60] 0 0
Turkey
State/province [60] 0 0
Kocaeli
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Bristol
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Hull
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Liverpool
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Manchester
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Newcastle upon Tyne
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Sunderland
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04657289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: WR42221 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04657289