A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • sponsor
    Kodiak Sciences Inc
Updated on 24 June 2021
macular edema
aflibercept
retinal vein occlusion
spectral domain optical coherence tomography

Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Description

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch and central type).

The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.

Details
Condition Macular Edema
Clinical Study IdentifierTX273660
SponsorKodiak Sciences Inc
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent prior to participation in the study
Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO
BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye
CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO
Other protocol-specified inclusion criteria may apply

Exclusion Criteria

Macular edema in the Study Eye for reasons other than RVO
Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye
Uncontrolled glaucoma in the Study Eye
Active retinal disease other than the condition under investigation in the Study Eye
Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
Active or suspected ocular or periocular infection or inflammation
Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation)
Women who are pregnant or lactating or intending to become pregnant during the study
Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
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
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
Other protocol-specified exclusion criteria may apply
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