A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

  • End date
    Nov 1, 2024
  • sponsor
    Kodiak Sciences Inc
Updated on 10 March 2022


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).


This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.

Condition Diabetes Mellitus Types I and II
Clinical Study IdentifierTX292077
SponsorKodiak Sciences Inc
Last Modified on10 March 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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