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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Wet Age-related Macular Degeneration

In brief

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)

Key facts

Study ID

NCT04964089

Run by

Kodiak Sciences Inc

People needed

557

Starts

2021-06-23

Expected to finish

2023-04-06

Last updated by the study team

2024-07-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Northwest Arkansas Retina Associates — Springdale, Arkansas, United States
• California Retina Consultants — Bakersfield, California, United States
• Eye Medical Center of Fresno — Fresno, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• UCSD Jacobs Retina Center — La Jolla, California, United States
• Retina Associates of Orange County — Laguna Hills, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retina Consultants of San Diego — Poway, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Retinal Consultants Medical Group Inc — Sacramento, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• Colorado Retina Associates PC — Lakewood, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Florida Eye Microsurgical Institute — Boynton Beach, Florida, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Retina Health Center — Fort Myers, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Retina Associates of Florida — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Springfield Clinic LLP — Springfield, Illinois, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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