Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

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)

Official Title

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 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)

Details

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-naïve 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

Keywords

Wet Age-related Macular Degeneration AMD Wet AMD neovascularization secondary to age-related macular degeneration KSI-301 Aflibercept Vascular endothelial growth factor VEGF Anti-VEGF Antibody biopolymer conjugate Macular Degeneration wAMD Retinal Degeneration Retinal Diseases Eye Diseases Vision Disorders Vision, Low Kodiak

Eligibility

You can join if…

Open to people ages 50 years and up

  • Signed informed consent prior to participation in the study.
  • Treatment-naïve 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

You CAN'T join if...

  • 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

Locations

  • UCSD Jacobs Retina Center not yet accepting patients
    La Jolla California 92037 United States
  • Eye Medical Center of Fresno not yet accepting patients
    Fresno California 93720 United States
  • Orange County Retina Medical Group not yet accepting patients
    Santa Ana California 92705 United States
  • Retina Associates of Orange County not yet accepting patients
    Laguna Hills California 92653 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kodiak Sciences Inc
ID
NCT04964089
Phase
Phase 3
Study Type
Interventional
Last Updated