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.

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Wet Macular Degeneration

In brief

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).

Key facts

Study ID

NCT04049266

Run by

Kodiak Sciences Inc

People needed

559

Starts

2019-10-08

Expected to finish

2022-04-26

Last updated by the study team

2024-07-18

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.
• 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 may not qualify 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.

Where it is running

• Northwest Arkansas Retina Associates — Springdale, Arkansas, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina Vitreous Associates — Beverly Hills, 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
• Retinal Consultants Medical Group Inc — Sacramento, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• California Retina Consultants — Santa Maria, California, United States
• Colorado Retina Associates PC — Lakewood, Colorado, 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
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Retina Associates PA — Lenexa, Kansas, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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