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)

KS301P106

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).

2021-08-30

2023-08-03

2023-08-31

Terminated

Early phase I

253

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 253, 'type': 'ACTUAL'}}

2024-04-11