A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

Key facts

Study ID

NCT04603937

Run by

Kodiak Sciences Inc

People needed

459

Starts

2020-09-30

Expected to finish

2023-08-31

Last updated by the study team

2024-08-22

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 diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening.
• BCVA ETDRS letter score between 78 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 DME.
• Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.
• Other protocol-specified inclusion criteria may apply.

You may not qualify if…

• Macular edema in the Study Eye considered to be secondary to a cause other than DME.
• Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.
• High-risk proliferative diabetic retinopathy characteristics in the Study Eye.
• History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening.
• Tractional retinal detachment 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 or affect macular edema or alter visual acuity during the study (e.g., vitreomacular traction, epiretinal membrane).
• Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.
• Any prior use of an approved or investigational treatment for DME 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

• Retina Vitreous Associates — Beverly Hills, California, United States
• Retina Consultants of Orange County — Fullerton, 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
• 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
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina, P.C. — Marietta, Georgia, United States
• Retina Consultants of Hawaii, Inc — ‘Aiea, Hawaii, United States
• Retina Specialists of Idaho — Boise, Idaho, United States
• Talley Eye — Evansville, Indiana, United States
• Maine Eye Center — Portland, Maine, United States
• Associated Retinal Consultants PC — Royal Oak, Michigan, United States
• Vitreoretinal Surgery PA — Minneapolis, Minnesota, United States
• Retina Consultants of NV — Henderson, Nevada, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Vitreo Retinal Consultants — Hauppauge, New York, United States
• Retina-Vitreous Surgeons of Central NY — Liverpool, New York, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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