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Report for Clinical Trial NCT04049266
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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).
3 Interventions
Name: KSI-301
Description: Intravitreal Injection
Type: Drug
Group Labels: 1 KSI-301 5 mg
Name: Aflibercept
Description: Intravitreal Injection
Type: Drug
Group Labels: 1 Aflibercept 2 mg
Name: Sham Procedure
Description: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Type: Other
Group Labels: 2 Aflibercept 2 mg KSI-301 5 mg
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
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 3 SNPs
SNPs
1 Q12W
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 ---
2 Q16W
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 ---
3 Q20W
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 ---
HPO Nodes