A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

Completed · Phase 3 · Has a placebo group

Conditions studied: Macular Edema, Retinal Vein Occlusion

In brief

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Key facts

Study ID

NCT04592419

Run by

Kodiak Sciences Inc

People needed

568

Starts

2020-09-25

Expected to finish

2023-01-19

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to participation in the study.
• Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
• BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
• CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
• Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
• Other protocol-specified inclusion criteria may apply.

You may not qualify if…

• Macular edema in the Study Eye for reasons other than RVO
• Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
• Uncontrolled glaucoma in the Study Eye.
• Active retinal disease other than the condition under investigation in the Study Eye.
• Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
• Active or suspected ocular or periocular infection or inflammation
• Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
• Women who are pregnant or lactating or intending to become pregnant during the study.
• Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
• 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.
• Other protocol-specified exclusion criteria may apply.

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, 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
• 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
• California Retina Consultants — Santa Maria, California, United States
• Colorado Retina Associates PC — Lakewood, Colorado, United States
• Conneticut Eye Consultants — Danbury, Connecticut, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Florida Eye Clinic — Altamonte Springs, Florida, United States
• Retina Group of Florida — Boca Raton, Florida, United States
• Florida Eye Microsurgical Institute — Boynton Beach, Florida, United States
• The Macula Center/ Blue Ocean Clinical Research — Clearwater, Florida, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Vitreo Retinal Associates — Gainesville, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Northwest Arkansas Retina Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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