Extension Study for the Port Delivery System With Ranibizumab (Portal)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorHoffmann-La Roche
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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"
Trial design
Design model
Parallel
Treatments tested in this trial
PDS Implant with Ranibizumab 100 mg/mL
DrugWill be administered as per the schedule described in individual arm
Treatment groups
1,000 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: PDS Implant Cohort 1 (US only)Experimental treatment 1 intervention
Group B: PDS Implant Cohort 2 (US only)Experimental treatment 1 intervention
Group C: PDS Implant Cohort 3 (US only)Experimental treatment 1 intervention
Group D: PDS Implant Cohort 4 (US only)Experimental treatment 1 intervention
Group E: PDS Implant Cohort 5 (ex-US only)Experimental treatment 1 intervention
Group F: PDS Implant Cohort 6 (ex-US only)Experimental treatment 1 intervention
Group G: PDS Implant Cohort 7 (ex-US only)Experimental treatment 1 intervention
Group H: Sub-study 1: PDS ImplantExperimental treatment 1 intervention
Group I: Sub-study 2: Cohort 1Experimental treatment 1 intervention
Group J: Sub-study 2: Cohort 2aExperimental treatment 1 intervention
Group K: Sub-study 2: Cohort 2bExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Time frame
Baseline up to Week 2402
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Time frame
Baseline up to Week 2403
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 2404
Incidence and Severity of Adverse Device Effects
Time frame
Baseline up to Week 240Secondary outcomes
1
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 2402
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Time frame
Baseline up to Week 2403
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 2404
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Time frame
Baseline up to Week 240Sponsors and contacts
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Source ClinicalTrials.gov