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

Phase 3TerminatedNCT05066230

Kodiak Sciences Inc253 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

253

Conditions

Non-proliferative Diabetic Retinopathy

Interventions

KSI-301DRUG

Intravitreal injection

Sham injectionOTHER

The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (61)

Outcomes

Primary Outcomes

Percentage of Patients Improving ≥2 Steps on DRSS

Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

Time frame: Day 1 to Week 48

Secondary Outcomes

Percentage of Patients Developing Any Sight-Threatening Complication

Percentage of patients developing any of the following Sight-Threatening Complication: Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), Vitreous hemorrhage or tractional retinal detachment believed to be due to PDR, or Diabetic Macular Edema (DME) from baseline through Week 48

Time frame: Day 1 to Week 48

Percentage of Patients Improving ≥3 Steps on DRSS

Percentage of patients improving ≥3 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

Time frame: Day 1 to Week 48

Percentage of Patients Developing PDR

Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48

Time frame: Day 1 to Week 48

Percentage of Patients Developing PDR or ASNV

Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) from baseline through Week 48

Data from ClinicalTrials.gov

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