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Extension Study for the Port Delivery System With Ranibizumab (Portal)
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.
Study details:
The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab .
Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-09-20
Primary completion: 2029-09-30
Study completion finish: 2029-09-30
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT03683251
Intervention or treatment
DRUG: PDS Implant with Ranibizumab 100 mg/mL
Conditions
- • Neovascular Age-Related Macular Degeneration
Find a site
Closest Location:
Eyeclinic Albury Wodonga
Research sites nearby
Select from list below to view details:
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Eye and Retina Consultants
Hurstville, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: PDS Implant Cohort 1 (US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 2 (US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 3 (US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 4 (US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 5 (ex-US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 6 (ex-US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: PDS Implant Cohort 7 (ex-US only)
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: Sub-study 1: PDS Implant
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: Sub-study 2: Cohort 1
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: Sub-study 2: Cohort 2a
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
EXPERIMENTAL: Sub-study 2: Cohort 2b
| DRUG: PDS Implant with Ranibizumab 100 mg/mL
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) | Not Specified | Baseline up to Week 240 |
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) | Not Specified | Baseline up to Week 240 |
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 | Not Specified | Baseline up to Week 240 |
Incidence and Severity of Adverse Device Effects | Not Specified | Baseline up to Week 240 |
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects | Not Specified | Baseline up to Week 240 |
Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery. | Not Specified | Baseline to Week 4 |
Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs | Not Specified | Baseline to Week 72 |
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs | Not Specified | Baseline to Week 72 |
Sub-study 2: Duration of AESIs | Not Specified | Baseline to Week 72 |
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period | Not Specified | Up to Day 37 post re-implantation |
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period | Not Specified | > 37 days post re-implantation (up to approximately Week 72) |
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period | Not Specified | Up to Day 37 post re-implantation |
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period | Not Specified | > 37 days post re-implantation (up to approximately Week 72) |
Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs | Not Specified | Baseline to Week 72 |
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs | Not Specified | Baseline to Week 72 |
Sub-study 2: Duration of Anticipated Serious ADEs | Not Specified | Baseline to Week 72 |
Sub-study 2: Number of Device Deficiencies | Not Specified | Baseline to Week 72 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | ETDRS = 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. | Baseline up to Week 240 |
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time | Not Specified | Baseline up to Week 240 |
Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time | Not Specified | Baseline up to Week 240 |
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time | Not Specified | Baseline up to Week 240 |
Change from Baseline in Center Point Thickness (CPT) Over Time | Not Specified | Baseline up to Week 240 |
Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg During Each Refill-exchange Interval | Not Specified | Baseline up to Week 240 |
Sub-study 1: Incidence of Ocular Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) in the Study eye | Not Specified | Baseline up to Week 104 |
Sub-study 1: Incidence of AEs Commonly Seen After Transscleral Cyclophotocoagulation (TS-CPC) for Treatment of Glaucoma in the Study eye | Not Specified | Baseline up to Week 104 |
Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye | Not Specified | Baseline up to Week 104 |
Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time | Not Specified | Baseline up to Week 104 |
Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time | Not Specified | Baseline up to Week 104 |
Sub-study 1: Rate of Vitrectomy in the Study eye | Not Specified | Baseline up to Week 104 |
Sub-study 1: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score From Baseline Over Time | Not Specified | Baseline up to Week 104 |
Sub-study 1: Change in BCVA Score From Baseline Over Time | Not Specified | Baseline up to Week 104 |
Sub-study 1: Change from Baseline in CPT Over Time | Not Specified | Baseline up to Week 104 |
Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time | Not Specified | Baseline up to Week 104 |
Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange | Not Specified | Up to approximately Week 72 |
Sub-study 2: Duration of AESIs Following Refill-exchange | Not Specified | Up to approximately Week 72 |
Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange | Not Specified | Up to approximately Week 72 |
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs Following Refill-exchange | Not Specified | Up to approximately Week 72 |
Sub-study 2: Number of Device Deficiencies Following Refill-exchange | Not Specified | Up to approximately Week 72 |
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