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Kodiak GLOW Study - Nonproliferative Diabetic Retinopathy (NPDR)

A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants with Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy (NPDR)

 

Condition or DiseaseIntervention / Treatment PhaseSponsor Status 
 Nonproliferative Diabetic Retinopathy

 KSI-301 or
Sham (Placebo)

3 Kodiak Science Inc.Enrolling

 

 

 

 

Description:

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).  Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.  To preserve masking (or the study blind), two investigators are required for this study.  The masked (blinded) investigator will be responsible for examinations and safety assessments.  The unmasked (unblinded) investigator will perform the study drug injections and post-treatment assessments.  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.

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.
Contacts:
Beachwood Office:  Dianne Himmelman  216-831-5700   •  dhimmelman@retina-assoc.com
 
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