SNPMiner Trials (Home Page)
Report for Mutation Q24W
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 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
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 MeSH:Macular Degeneration Wet Macular Degeneration
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 144Measure: 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 144Measure: 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
2 A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)
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 MeSH:Macular Edema Edema
HPO:Anasarca Cystoid macular edema Edema Macular edema
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 64Secondary 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 64Measure: 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 64Measure: 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 120Description: 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 120Measure: 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