A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)

Kodiak Sciences Inc11 sites in 1 country121 target enrollmentDecember 26, 2018

ConditionsWet Age-related Macular Degeneration Retinal Vein Occlusion Diabetic Macular Edema

InterventionsKSI-301

DrugsKSI-301

Overview

Phase: Phase 1
Intervention: KSI-301
Conditions: Wet Age-related Macular Degeneration
Sponsor: Kodiak Sciences Inc
Enrollment: 121
Locations: 11
Primary Endpoint: Incidence of ocular (study eye) and systemic adverse events
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg

Registry

clinicaltrials.gov

Start Date

December 26, 2018

End Date

June 9, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kodiak Sciences Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Wet AMD Cohort
•Treatment naïve wet age-related macular degeneration involving the fovea.
•A lesion area \<30 mm2 (12 disc areas) of any lesion type.
•BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
•Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
•Treatment naïve diabetic macular edema.
•BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
•Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
•Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
•Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.

Exclusion Criteria

•Wet AMD Cohort:
•Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
•Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
•Prior intravitreal anti-VEGF therapy in the study eye.
•DME Cohort:
•Initial diagnosis of DME of more than 6 months from screening in the study eye.
•Hard exudates in the fovea.
•Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
•Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
•Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.