SNPMiner Trials (Home Page)
Report for Mutation Q24W
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
This study will evaluate the long-term safety and tolerability of the Port Delivery System
with ranibizumab (PDS) 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration who
have completed either Phase II Study GX28228 (Ladder) or Phase III Study GR40548 (Archway).
NCT03683251 Neovascular Age-Related Macular Degeneration Drug: PDS Implant with Ranibizumab 100 mg/mL
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 with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration who
have completed either Phase II Study GX28228 (Ladder) or Phase III Study GR40548 (Archway). --- Q24W ---
Primary Outcomes
Measure: Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Time: Baseline up to Week 144
Measure: Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Time: Baseline up to Week 144
Measure: 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: Baseline up to Week 144
Secondary Outcomes
Description: 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.
Measure: 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
Time: Baseline up to Week 144
Measure: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Time: Baseline up to Week 144
Measure: Percentage of Participants with BCVA Score of 34 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time
Time: Baseline up to Week 144
Measure: Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Time: Baseline up to Week 144
Measure: Change from Baseline in Center Point Thickness Over Time
Time: Baseline up to Week 144
Measure: Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill Interval
Time: Weeks 16 to Week 136
This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery
System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated
every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).
NCT04108156 Diabetic Macular Edema Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab Drug: Intravitreal Ranibizumab 0.5 mg Injection
This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab
This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery
System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated
every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W). --- Q24W ---
Primary Outcomes
Description: BCVA = Best-Corrected Visual Acuity
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.
Measure: Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart
Time: Baseline to Week 64
Secondary Outcomes
Description: ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64
Time: Baseline to Week 64
Measure: Change from baseline in BCVA as measured on the ETDRS chart over time
Time: Baseline up to Week 120
Measure: Percentage of participants who lose <10, and <5 letters in BCVA from baseline over time
Time: Baseline up to Week 120
Measure: Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS at Week 64
Time: Baseline to Week 64
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥2-step worsening from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥3-step worsening from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Change from baseline in ETDRS-DRSS score over time
Time: Baseline up to Week 120
Description: CST = central subfield thickness
SD-OCT = spectral domain optical coherence tomography
Measure: Change from baseline in CST as measured on SD-OCT at Week 64
Time: Baseline to Week 64
Measure: Change from baseline in CST as measured on SD-OCT over time
Time: Baseline up to Week 120
Measure: Change from baseline in total macular volume as measured on SD-OCT over time
Time: Baseline up to Week 120
Description: DME = diabetic macular edema
Measure: Percentage of participants with DME (defined as CST ≥325 μm on SD-OCT) over time
Time: Baseline up to Week 120
Description: PDR = proliferative diabetic retinopathy
Measure: Percentage of participants with PDR (defined as a score ≥60 on the ETDRS-DRSS) over time
Time: Baseline up to Week 120
Measure: Incidence and severity of ocular adverse events
Time: Baseline to Week 120
Measure: Incidence and severity of non-ocular adverse events
Time: Baseline up to Week 120
Measure: Incidence, severity, and duration of adverse events of special interest
Time: Baseline up to Week 120
Measure: Incidence, severity, and duration of PDS-associated adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (>37 days after implantation surgery)
Time: Baseline up to Week 120
Measure: Serum concentration of ranibizumab observed over time
Time: Baseline up to Week 120
Measure: PK parameter value area under the concentration- time curve over 24 weeks (AUC24W)
Time: Baseline to Week 24
Measure: Pharmacokinetic (PK) parameter maximum serum concentration (Cmax)
Time: Baseline up to Week 120
Measure: PK Parameter minimum serum concentration (Cmin)
Time: Baseline up to Week 120
Measure: PK parameter half-life (t1/2) after PDS implant insertion
Time: Baseline up to Week 120
Measure: Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Time: Baseline up to Week 120
HPO Nodes
Genes 14
REEP6 POMGNT1 PRPH2 ARL3 ARHGEF18 RHO DHDDS NOD2 PDE6G MFRP PRPF8 RLBP1 HLA-A RDH5 hr>
Genes 3
PMM2 PLVAP UBR1 hr>