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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,000
Will be administered as per the schedule described in individual arm
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Time frame: Baseline up to Week 240
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Time frame: 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
Time frame: Baseline up to Week 240
Incidence and Severity of Adverse Device Effects
Time frame: Baseline up to Week 240
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
Time frame: 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.
Time frame: Baseline to Week 4
Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs
Time frame: Baseline to Week 72
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs
Time frame: Baseline to Week 72
Sub-study 2: Duration of AESIs
Time frame: Baseline to Week 72
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period
Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below.
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Retinal Research Institute, LLC
Phoenix, Arizona, United States
COMPLETEDArizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
COMPLETEDBarnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGAssociated Retina Consultants
Phoenix, Arizona, United States
COMPLETEDRetinal Consultants of Arizona
Phoenix, Arizona, United States
COMPLETEDCalifornia Retina Consultants
Bakersfield, California, United States
COMPLETEDRetina-Vitreous Associates Medical Group
Beverly Hills, California, United States
COMPLETEDThe Retina Partners
Encino, California, United States
ACTIVE_NOT_RECRUITINGJacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California, United States
COMPLETEDJules Stein Eye Institute/ UCLA
Los Angeles, California, United States
COMPLETED...and 155 more locations
Time frame: 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
Time frame: > 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period
Time frame: Up to Day 37 post re-implantation
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period
Time frame: > 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
Time frame: Baseline to Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs
Time frame: Baseline to Week 72
Sub-study 2: Duration of Anticipated Serious ADEs
Time frame: Baseline to Week 72
Sub-study 2: Number of Device Deficiencies
Time frame: Baseline to Week 72
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.
Time frame: Baseline up to Week 240
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Time frame: Baseline up to Week 240
Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time
Time frame: Baseline up to Week 240
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Time frame: Baseline up to Week 240
Change from Baseline in Center Point Thickness (CPT) Over Time
CPT is defined as the retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT is measured using optical coherence tomography (OCT).
Time frame: Baseline up to Week 240
Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg During Each Refill-exchange Interval
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 104
Sub-study 1: Time From Surgery to Vitreous Hemorrhage Resolution in the Study eye
Time frame: Baseline up to Week 104
Sub-study 1: Incidence of Vitreous Hemorrhage Grade 3 and Higher in the Study eye over time
Time frame: Baseline up to Week 104
Sub-study 1: Distribution of Vitreous Hemorrhage Grade in the Study eye Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Rate of Vitrectomy in the Study eye
Time frame: 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
Time frame: Baseline up to Week 104
Sub-study 1: Change in BCVA Score From Baseline Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Change from Baseline in CPT Over Time
Time frame: Baseline up to Week 104
Sub-study 1: Change From Baseline in Center Subfield Thickness (CST) Over Time
Time frame: Baseline up to Week 104
Sub-study 2: Number of Participants with Ocular AESIs and Severity of AESIs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Duration of AESIs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Number of Participants With ADEs and Severity of ADEs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs Following Refill-exchange
Time frame: Up to approximately Week 72
Sub-study 2: Number of Device Deficiencies Following Refill-exchange
Time frame: Up to approximately Week 72