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

Kodiak Sciences

Status and phase: Terminated; Phase 3

Conditions: Non-proliferative Diabetic Retinopathy

Treatments: Drug: KSI-301; Other: Sham injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05066230

KS301P106

Details and patient eligibility

About

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).

Full 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).

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.

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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253 participants in 2 patient groups

KSI-301 - Treatment Group A

Experimental group

Description:

Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92

Treatment:

Drug: KSI-301

Treatment Group B

Sham Comparator group

Description:

Sham injection on the same schedule as Treatment Group A

Treatment:

Other: Sham injection