SNPMiner Trials by Shray Alag

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Report for Mutation Q20W

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 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 --- --- Q16W --- --- Q20W ---

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 1

Secondary Outcomes

Measure: Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.

Time: Year 1

Measure: 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

HPO Nodes