SNPMiner Trials by Shray Alag

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SNPMiner 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 (Portal)

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome).

NCT03683251
Conditions
  1. Neovascular Age-Related Macular Degeneration
Interventions
  1. 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 refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome). --- Q24W ---

Inclusion Criteria: - 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 Exclusion Criteria: - 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" Inclusion Criteria: - 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 Exclusion Criteria: - 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" Neovascular Age-Related Macular Degeneration Macular Degeneration Wet Macular Degeneration null --- Q24W ---

Inclusion Criteria: - 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 Exclusion Criteria: - 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" Inclusion Criteria: - 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 Exclusion Criteria: - 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" Neovascular Age-Related Macular Degeneration Macular Degeneration Wet Macular Degeneration null --- Q24W --- --- Q36W --- --- 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 38 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-exchange 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
Conditions
  1. Diabetic Macular Edema
Interventions
  1. Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
  2. 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