SNPMiner Trials (Home Page)
Report for Mutation Q12W
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 5 clinical trials
Clinical Trials
1 A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
NCT02387957 Age-Related Macular Degeneration Drug: Fovista® Drug: bevacizumab Drug: ranibizumab Drug: aflibercept MeSH:Macular Degeneration
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months. --- Q12W ---
Primary Outcomes
Description: Number of Patients with Systemic Adverse Events
Measure: Total Numer of Systemic Adverse Events Time: 2 yearsDescription: Number of Patients with Other Adverse Events
Measure: Total Number of Other Adverse Events (>5%) Time: 2 years2 A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma
This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.
NCT02626130 Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Cancer Stage IV Renal Cell Cancer AJCC v7 Procedure: Cryosurgery Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery Biological: Tremelimumab MeSH:Carcinoma Carcinoma, Renal Cell
HPO:Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma
After surgery or biopsy, patients receive tremelimumab IV every 4 weeks (Q4W) for 3 doses, and then every 12 weeks (Q12W) in the absence of disease progression or unacceptable toxicity. --- Q12W ---
After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity. --- Q12W ---
Primary Outcomes
Description: Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm. Descriptive statistical analyses will be performed to summarize the incidence of adverse events.
Measure: Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 Time: Up to 2 weeksDescription: Extreme toxicities will be defined as any grade 3 or higher adverse event that is possibly, probably, or definitely related to therapy that occurs within the first two cycles of therapy with the following exceptions: any grade 3 or higher adverse event that is potentially treatable with steroids will only count as an extreme toxicity if it does not improve to grade 1 or better within 2 weeks of steroid therapy, grade 3 or 4 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis, or grade 3 or 4 drug related endocrinopathies which within two weeks of presentation are adequately controlled with only physiologic hormone replacement therapy.
Measure: Incidence of extreme toxicities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 Time: Up to 2 weeksSecondary Outcomes
Description: Descriptive statistical analyses will be performed to summarize the response rate including summary tables, scatter-plots, box-plots, proportions, 95% credible intervals, median, means, and standard deviations.
Measure: Response rate Time: Up to 5 yearsDescription: Differences of indication markers between arms will be compared using a t-test with transformations of non-normal data, as needed. A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Changes in indication markers Time: Up to 5 yearsDescription: Descriptive statistical analyses will be performed.
Measure: Progression free survival Time: Up to 5 yearsDescription: A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Longitudinal data on immunological values over time Time: Up to 13 weeks3 A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
NCT03622580 Diabetic Macular Edema Drug: Aflibercept Drug: Faricimab Drug: Sham Procedure MeSH:Macular Edema Edema
HPO:Anasarca Cystoid macular edema Edema Macular edema
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---
Primary Outcomes
Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year Time: Baseline (Day 1) and 1 yearSecondary Outcomes
Measure: Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year Time: Baseline and 1 yearMeasure: Change From Baseline in BCVA Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time Time: Up to 2 years
Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time Time: Up to 2 years
Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time Time: Up to 2 years
Measure: Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time Time: Up to 2 years
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year Time: 1 year
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years Time: 2 years
Measure: Change From Baseline in Central Subfield Thickness Over Time Time: From Baseline up to 2 years
Measure: Change From Baseline in Central Subfield Thickness at 1 Year Time: Baseline and 1 year
Measure: Percentage of Participants with Absence of DME Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time Time: Up to 2 years
Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants with At Least One Ocular Adverse Event Time: Up to 2 years
Measure: Percentage of Participants with At Least One Non-Ocular Adverse Event Time: Up to 2 years
Measure: Plasma Concentration of Faricimab Over Time Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
Measure: Percentage of Participants with Presence of Anti-Drug Antibodies Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
4 A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME). The global enrollment phase has closed, but participants are still being recruited only at sites in China.
NCT03622593 Diabetic Macular Edema Drug: Aflibercept Drug: Faricimab Drug: Sham Procedure MeSH:Macular Edema Edema
HPO:Anasarca Cystoid macular edema Edema Macular edema
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---
Primary Outcomes
Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year Time: Baseline (Day 1) and 1 yearSecondary Outcomes
Measure: Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year Time: Baseline and 1 yearMeasure: Change From Baseline in BCVA Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time Time: Up to 2 years
Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time Time: Up to 2 years
Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time Time: Up to 2 years
Measure: Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time Time: Up to 2 years
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year Time: 1 year
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years Time: 2 years
Measure: Change From Baseline in Central Subfield Thickness Over Time Time: From Baseline up to 2 years
Measure: Change From Baseline in Central Subfield Thickness at 1 Year Time: Baseline and 1 year
Measure: Percentage of Participants with Absence of DME Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time Time: Up to 2 years
Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time Time: From Baseline up to 2 years
Measure: Percentage of Participants with At Least One Ocular Adverse Event Time: Up to 2 years
Measure: Percentage of Participants with At Least One Non-Ocular Adverse Event Time: Up to 2 years
Measure: Plasma Concentration of Faricimab Over Time Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
Measure: Percentage of Participants with Presence of Anti-Drug Antibodies Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
5 A Phase 2, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
NCT04049266 Wet Macular Degeneration Drug: KSI-301 Drug: Aflibercept Other: Sham Procedure MeSH:Macular Degeneration Wet Macular Degeneration
Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.. BCVA is measured using ETDRS visual acuity charts.. Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.. null. --- Q12W ---
Primary Outcomes
Description: BCVA is measured using ETDRS visual acuity charts.
Measure: Mean change in Best Corrected Visual Acuity (BCVA) from Day 1. Time: Year 1Secondary Outcomes
Measure: Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301. Time: Year 1Measure: Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1. Time: Year 1
Measure: Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1. Time: Year 1
Measure: Proportion of subjects with BCVA Snellen equivalent of 20/40 or better. Time: Year 1
Measure: Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse. Time: Year 1
Measure: Mean change in OCT central subfield retinal thickness (CST) from Day 1. Time: Year 1
Measure: Mean change in OCT intraretinal fluid volume from Day 1. Time: Year 1
Measure: Mean change in OCT subretinal fluid volume from Day 1. Time: Year 1
Measure: Proportion of subjects without intraretinal fluid on OCT. Time: Year 1
Measure: Proportion of subjects without subretinal fluid on OCT. Time: Year 1
Measure: Mean change in CNV total lesion area on FA from baseline. Time: Year 1
Measure: Mean chance in area of leakage on FA from baseline. Time: Year 1