A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

a study on Macular Degeneration

Summary

for people ages 50 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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 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.

Details

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.

Keywords

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 Antibodies KSI-301 5 mg Aflibercept 2 mg

Eligibility

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.

Locations

  • UCSD Jacobs Retina Center accepting new patients
    La Jolla California 92037 United States
  • Retina Consultants of San Diego accepting new patients
    Poway California 92064 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kodiak Sciences Inc
ID
NCT04049266
Phase
Phase 2
Study Type
Interventional
Last Updated