SNPMiner Trials: Mutation Report
Report for Mutation Q24W
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
This study will evaluate the long-term safety and tolerability of the Port Delivery System
(PDS) with ranibizumab 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration
(nAMD) who have completed either Phase II Study GX28228 or Phase III Study GR40548.
NCT03683251 Neovascular Age-Related Macular Degeneration Drug: PDS Implant with Ranibizumab 100 mg/mL
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
(PDS) with ranibizumab 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration
(nAMD) who have completed either Phase II Study GX28228 or Phase III Study GR40548. --- 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), Including PDS-Associated AEs
Time: Baseline up to Week 144
Measure: Incidence, Severity, and Duration of PDS-Associated Ocular AEs During the Postoperative Period (Up to 4 Weeks of Initial Implantation) and Follow-Up Period (>4 Weeks After Implantation Surgery) for Participants who Receive the Implant in the Study
Time: Baseline up to Week 144
Secondary 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 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 Rescue Treatment of Intravitreal Ranibizumab Before the First, Second, Third, Fourth, and Fifth Refill Interval
Time: Weeks 16 to Week 136
HPO Nodes