A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    500
  • sponsor
    Kodiak Sciences Inc
Updated on 30 July 2021
Investigator
Kodiak Sciences Inc
Primary Contact
Ophthalmic Consultants of Boston (6.0 mi away) Contact
+65 other location

Summary

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Description

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-nave neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time

Details
Condition Wet Age Related Macular Degeneration
Treatment Aflibercept, Sham Procedure, KSI-301
Clinical Study IdentifierNCT04964089
SponsorKodiak Sciences Inc
Last Modified on30 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent prior to participation in the study
Treatment-nave choroidal neovascularization (CNV) secondary to AMD
BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye
Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD
Other protocol-specified inclusion criteria may apply

Exclusion Criteria

BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
Active or suspected ocular or periocular infection or inflammation
CNV secondary to other causes in the Study Eye
Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study
Uncontrolled glaucoma in the Study Eye
Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography
Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening
Women who are pregnant or lactating or intending to become pregnant during the study
Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event
History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
Uncontrolled blood pressure defined as a systolic value 180 mmHg or diastolic value 100 mmHg while at rest
Other protocol-specified exclusion criteria may apply
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