A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non-proliferative Diabetic Retinopathy

In brief

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Key facts

Study ID

NCT05066230

Run by

Kodiak Sciences Inc

People needed

253

Starts

2021-09-07

Expected to finish

2023-08-31

Last updated by the study team

2024-09-05

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.
• Type 1 or 2 diabetes mellitus
• Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
• BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
• HbA1c of ≤12%.
• Other protocol-specified inclusion criteria may apply.

You may not qualify if…

• Presence of center-involved DME in the Study Eye
• Prior PRP in the Study Eye.
• Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
• Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
• Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
• Prior use of an investigational intravitreal treatment for DR or DME 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 alter visual acuity during the study
• Active or suspected ocular or periocular infection or inflammation.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• 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.
• 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.
• 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

• Retina Vitreous Associates — Beverly Hills, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Retinal Consultants Medical Group Inc — Sacramento, California, United States
• California Retina Consultants - Santa Maria — Santa Maria, California, United States
• Connecticut Eye Consultants — Danbury, Connecticut, United States
• Retina Group of New England — Waterford, Connecticut, United States
• The Macula Center/ Blue Ocean Clinical Research — Clearwater, Florida, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Med Eye Associates — Miami, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Center for Retina & Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Retina Specialists of Idaho — Boise, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• Springfield Clinic LLP — Springfield, Illinois, United States
• Retina Associates PA — Lenexa, Kansas, United States
• Cumberland Valley Retina Consultants PC — Hagerstown, Maryland, United States
• Foundation for Vision Research — Grand Rapids, Michigan, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Envision Ocular LLC — Bloomfield, New Jersey, United States
• Long Island Vitreoretinal Consultants — Hauppauge, New York, United States
• Ophthalmic Consultants of Long Island — Oceanside, New York, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.