SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation Q36W

Developed by Shray Alag, 2020-2021.
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 --- --- Q36W ---

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 ---

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 --- --- Q36W ---

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 IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked Study Of The Efficacy, Safety, And Pharmacokinetics Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

NCT04657289
Conditions
  1. Neovascular Age-related Macular Degeneration (nAMD)
Interventions
  1. Drug: PDS Implant filled with 100 mg/mL Ranibizumab
MeSH:Macular Degeneration Wet Macular Degeneration

A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD). --- Q36W ---

Incidence and severity of ocular and systemic (non-ocular) adverse events in Q36W compared with Q24W. --- Q36W ---

Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W. --- Q36W ---

Primary Outcomes

Description: EDTRS = 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 from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters

Time: Baseline to Week 72

Secondary Outcomes

Measure: Change from baseline in BCVA score over time

Time: Baseline up to Week 72

Measure: Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72

Time: Baseline to Week 72

Measure: Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time

Time: Baseline up to Week 72

Measure: Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72

Time: Baseline to Week 72

Measure: Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time

Time: Baseline up to Week 72

Measure: Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 40

Time: At Week 40

Measure: Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at Week 40

Time: At Week 40

Measure: Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72

Time: Baseline to Week 72

Measure: Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time

Time: Baseline up to Week 72

Measure: Change from baseline in center point thickness (CPT) up to and including Week 72

Time: Baseline up to Week 72

Measure: Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure

Time: Week 16 to Week 68

Measure: Incidence and severity of ocular and systemic (non-ocular) adverse events in Q36W compared with Q24W

Time: Baseline up to Week 72

Measure: Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W

Time: Baseline up to Week 72

Measure: Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 days of initial implantation) and follow-up period (> 37 days after implantation surgery) in all enrolled participants

Time: Baseline up to Week 72

Measure: Observed serum concentration of ranibizumab at specified timepoints

Time: Baseline to Week 72

Measure: Incidence of treatment-emergent ADAs during the study

Time: Baseline to Week 72


HPO Nodes