SNPMiner Trials by Shray Alag


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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 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

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 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


Cystoid macular edema
Genes 14
REEP6 POMGNT1 PRPH2 ARL3 ARHGEF18 RHO DHDDS NOD2 PDE6G MFRP PRPF8 RLBP1 HLA-A RDH5
Anasarca
Genes 3
PMM2 PLVAP UBR1