for people ages 50 years and up (full criteria)
study started
estimated completion



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).

Official Title

A Phase 2b/3, 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 is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg. At Week 52 patients on the aflibercept treatment arm will be re-randomized 1:1 into KSI-301 5 mg and aflibercept 2 mg.


Wet Macular Degeneration AMD Wet AMD choroidal neovascularization secondary to age-related macular degeneration KSI-301 Aflibercept Vascular endothelial growth factor VEGF Anti-VEGF Antibody biopolymer conjugate Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Vision Disorders Vision, low Kodiak KSI-301 5 mg Aflibercept 2 mg


You can join if…

Open to people ages 50 years and up

  • Signed informed consent prior to participation in the study.
  • Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
  • Other protocol-specified inclusion criteria may apply

You CAN'T join if...

  • CNV secondary to other causes in the Study Eye.
  • Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
  • Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
  • Active ocular or periocular infection or inflammation.
  • Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
  • Uncontrolled glaucoma in the Study Eye.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • Stroke or myocardial infarction in the 6-month period prior to Day 1.
  • Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest.
  • 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.
  • Other protocol-specified exclusion criteria may apply.


  • UCSD Jacobs Retina Center
    La Jolla California 92037 United States
  • Retina Vitreous Associates
    Beverly Hills California 90211 United States
  • Eye Medical Center of Fresno
    Fresno California 93720 United States
  • Orange County Retina Medical Group
    Santa Ana California 92705 United States
  • Retina Associates of Orange County
    Laguna Hills California 92653 United States


in progress, not accepting new patients
Start Date
Completion Date
Kodiak Sciences Inc
Phase 2/3
Study Type
Last Updated