A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • sponsor
    Kodiak Sciences Inc
Updated on 24 June 2021

Summary

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

Description

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME.

The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.

Details
Condition Diabetic Macular Edema
Clinical Study IdentifierTX273659
SponsorKodiak Sciences Inc
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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