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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03683251




Registration number
NCT03683251
Ethics application status
Date submitted
18/09/2018
Date registered
25/09/2018
Date last updated
15/10/2024

Titles & IDs
Public title
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Scientific title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)
Secondary ID [1] 0 0
2020-004427-16
Secondary ID [2] 0 0
GR40549
Universal Trial Number (UTN)
Trial acronym
Portal
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-Related Macular Degeneration 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 - PDS Implant with Ranibizumab 100 mg/mL

Experimental: PDS Implant Cohort 1 (US only) - Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.

Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

Experimental: PDS Implant Cohort 2 (US only) - Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.

Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

Experimental: PDS Implant Cohort 3 (US only) - Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.

Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

Experimental: PDS Implant Cohort 4 (US only) - Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.

Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

Experimental: PDS Implant Cohort 5 (ex-US only) - Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W

Experimental: PDS Implant Cohort 6 (ex-US only) - Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W

Experimental: PDS Implant Cohort 7 (ex-US only) - Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W

Experimental: Sub-study 1: PDS Implant - Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W.

Experimental: Sub-study 2: Cohort 1 - Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W

Experimental: Sub-study 2: Cohort 2a - Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.

Experimental: Sub-study 2: Cohort 2b - Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.


Treatment: Drugs: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Timepoint [1] 0 0
Baseline up to Week 240
Primary outcome [2] 0 0
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Timepoint [2] 0 0
Baseline up to Week 240
Primary outcome [3] 0 0
Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study
Timepoint [3] 0 0
Baseline up to Week 240
Primary outcome [4] 0 0
Incidence and Severity of Adverse Device Effects
Timepoint [4] 0 0
Baseline up to Week 240
Primary outcome [5] 0 0
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
Timepoint [5] 0 0
Baseline up to Week 240
Primary outcome [6] 0 0
Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery.
Timepoint [6] 0 0
Baseline to Week 4
Primary outcome [7] 0 0
Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs
Timepoint [7] 0 0
Baseline to Week 72
Primary outcome [8] 0 0
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs
Timepoint [8] 0 0
Baseline to Week 72
Primary outcome [9] 0 0
Sub-study 2: Duration of AESIs
Timepoint [9] 0 0
Baseline to Week 72
Primary outcome [10] 0 0
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period
Timepoint [10] 0 0
Up to Day 37 post re-implantation
Primary outcome [11] 0 0
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period
Timepoint [11] 0 0
> 37 days post re-implantation (up to approximately Week 72)
Primary outcome [12] 0 0
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period
Timepoint [12] 0 0
Up to Day 37 post re-implantation
Primary outcome [13] 0 0
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period
Timepoint [13] 0 0
> 37 days post re-implantation (up to approximately Week 72)
Primary outcome [14] 0 0
Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs
Timepoint [14] 0 0
Baseline to Week 72
Primary outcome [15] 0 0
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs
Timepoint [15] 0 0
Baseline to Week 72
Primary outcome [16] 0 0
Sub-study 2: Duration of Anticipated Serious ADEs
Timepoint [16] 0 0
Baseline to Week 72
Primary outcome [17] 0 0
Sub-study 2: Number of Device Deficiencies
Timepoint [17] 0 0
Baseline to Week 72
Secondary outcome [1] 0 0
Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
Timepoint [1] 0 0
Baseline up to Week 240
Secondary outcome [2] 0 0
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Timepoint [2] 0 0
Baseline up to Week 240
Secondary outcome [3] 0 0
Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time
Timepoint [3] 0 0
Baseline up to Week 240
Secondary outcome [4] 0 0
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Timepoint [4] 0 0
Baseline up to Week 240
Secondary outcome [5] 0 0
Change from Baseline in Center Point Thickness (CPT) Over Time
Timepoint [5] 0 0
Baseline up to Week 240
Secondary outcome [6] 0 0
Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg During Each Refill-exchange Interval
Timepoint [6] 0 0
Baseline up to Week 240
Secondary outcome [7] 0 0
Sub-study 1: Incidence of Ocular Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) in the Study eye
Timepoint [7] 0 0
Baseline up to Week 104
Secondary outcome [8] 0 0
Sub-study 1: Incidence of AEs Commonly Seen After Transscleral Cyclophotocoagulation (TS-CPC) for Treatment of Glaucoma in the Study eye
Timepoint [8] 0 0
Baseline up to Week 104
Secondary outcome [9] 0 0
Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye
Timepoint [9] 0 0
Baseline up to Week 104
Secondary outcome [10] 0 0
Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time
Timepoint [10] 0 0
Baseline up to Week 104
Secondary outcome [11] 0 0
Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time
Timepoint [11] 0 0
Baseline up to Week 104
Secondary outcome [12] 0 0
Sub-study 1: Rate of Vitrectomy in the Study eye
Timepoint [12] 0 0
Baseline up to Week 104
Secondary outcome [13] 0 0
Sub-study 1: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score From Baseline Over Time
Timepoint [13] 0 0
Baseline up to Week 104
Secondary outcome [14] 0 0
Sub-study 1: Change in BCVA Score From Baseline Over Time
Timepoint [14] 0 0
Baseline up to Week 104
Secondary outcome [15] 0 0
Sub-study 1: Change from Baseline in CPT Over Time
Timepoint [15] 0 0
Baseline up to Week 104
Secondary outcome [16] 0 0
Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time
Timepoint [16] 0 0
Baseline up to Week 104
Secondary outcome [17] 0 0
Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange
Timepoint [17] 0 0
Up to approximately Week 72
Secondary outcome [18] 0 0
Sub-study 2: Duration of AESIs Following Refill-exchange
Timepoint [18] 0 0
Up to approximately Week 72
Secondary outcome [19] 0 0
Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange
Timepoint [19] 0 0
Up to approximately Week 72
Secondary outcome [20] 0 0
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs Following Refill-exchange
Timepoint [20] 0 0
Up to approximately Week 72
Secondary outcome [21] 0 0
Sub-study 2: Number of Device Deficiencies Following Refill-exchange
Timepoint [21] 0 0
Up to approximately Week 72

Eligibility
Key inclusion criteria
* Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
* Ability and willingness to undertake all scheduled visits and assessments
* For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
* History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
* History of other diseases, 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 that renders the participant at high risk of treatment complications
* Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

Sub-study 1

Inclusion Criteria

- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures

Participants must meet the following ocular criteria for the study eye for substudy entry:

* Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
* Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit
* Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:

Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)

* All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).
* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.

Exclusion Criteria Prior Ocular Treatments Study Eye

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
* Previous treatment with corticosteroid ITV injection
* Previous intraocular device implantation
* Previous laser (any type) used for AMD treatment

Either Eye

* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
* Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab

CNV Lesion Charateristics Study Eye

* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
* Subfoveal fibrosis or subfoveal atrophy

Either Eye

- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia

Concurrent Ocular Conditions Study Eye

* Retinal pigment epithelial tear
* Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) 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
* Active intraocular inflammation (grade trace or above)
* History of vitreous hemorrhage
* History of rhegmatogenous retinal detachment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Aphakia or absence of the posterior capsule
* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
* Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* History of corneal transplant
* History of prior vitrectomy surgery and absence of posterior capsule

Either Eye

* History of idiopathic or autoimmune-associated uveitis
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Concurrent Systemic Conditions

* Inability to comply with study schedule or procedures as described in the study protocol
* Uncontrolled blood pressure
* History of stroke within the last 3 months prior to informed consent
* Uncontrolled atrial fibrillation within 3 months of 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 patient at high risk of treatment complications in the opinion of the investigator
* Current systemic treatment for a confirmed active systemic infection
* Use of any systemic anti-VEGF agents
* Chronic use of oral corticosteroids
* Active cancer within 12 months of enrollment
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
* History of albinism
* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Sub-study 2

Inclusion Criteria:

* Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye
* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center

Exclusion Criteria (Cohort 1 only):

Concurrent Ocular Conditions-Study Eye

* Any ocular condition that may render the patient at high risk for surgical or treatment complications
* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
* Ongoing ocular complications that might affect participant safety

Concurrent Ocular Conditions-Either Eye

* Suspected or active ocular or periocular infection
* Any history of uveitis
* Active blepharitis

Concurrent Systemic Conditions

* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
* Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
20/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2029
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Eye and Retina Consultants - Hurstville
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
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Iowa
Country [9] 0 0
United States of America
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Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
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Massachusetts
Country [14] 0 0
United States of America
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Michigan
Country [15] 0 0
United States of America
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Minnesota
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Capital Federal
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Argentina
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Rosario
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Austria
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Graz
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Austria
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Wien
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Belgium
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Leuven
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Brazil
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GO
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Brazil
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MG
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Brazil
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RJ
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Brazil
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SC
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Brazil
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SP
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France
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Bordeaux
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France
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Paris
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Germany
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Ulm
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Italy
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Lazio
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Barcelona
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Binningen
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Switzerland
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Lausanne
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Switzerland
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Zürich
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
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Zhongzheng Dist.
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
State/province [67] 0 0
Sunderland

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
Trial website
https://clinicaltrials.gov/study/NCT03683251
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: GR40549 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/NCT03683251