NCT03790852

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 wAMD, DME and RVO

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Kodiak Sciences Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Wet Age-related Macular Degeneration
• Retinal Vein Occlusion
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	KSI-301	Intravitreal injection

Timeline

• Start date: 2018-12-26
• Primary completion: 2021-06-02
• Completion: 2022-06-09
• First posted: 2019-01-02
• Last updated: 2024-03-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study